BackgroundIn childhood cancer care, healthcare professionals must deal with several difficult moral situations in clinical practice. Previous studies show that morally difficult challenges are related to decisions on treatment limitations, infringing on the child's integrity and growing autonomy, and interprofessional conflicts. Research also shows that healthcare professionals have expressed a need for clinical ethics support to help them deal with morally difficult situations. Moral case deliberations (MCDs) are one example of ethics support. The aim of this study was to describe (...) the MCD-related outcomes that healthcare professionals in childhood cancer care considered important, before MCDs were implemented, in order to facilitate the implementation of MCDs in childhood cancer care in Sweden.MethodsThis study is based on qualitative data. Healthcare professionals, mostly representing registered nurses, nursing assistants and physicians, working at childhood cancer care centres in Sweden, were invited to respond to the translated and content validated European MCD Outcomes Instrument, before participating in regular MCDs. Answers to the main open-ended question, included in the questionnaire, was analysed according to systematic text condensation.ResultsData was collected from 161 responses from the healthcare professionals. The responses included healthcare professionals’ perceptions of which MCD-related outcomes they found important for handling moral challenges. Three different themes of important outcomes from the analysis of the data are presented as follows:Interprofessional well-being in team interactionson a team level;Professional comfort when dealing with moral challengeson a personal level; andImproved quality of care for the child and the familyon a care level.ConclusionsHealthcare professionals in childhood cancer care considered it important that ethics support could enhance the well-being of interprofessional teams, support healthcare professionals on an individual level and improve quality of care. The results of this study can be used in current and future training for MCD-facilitators. When knowing the context specific important MCD-outcomes, the sessions could be adapted. Managers in childhood cancer care would benefit from knowing about the specific important outcomes for their target group because they could then create relevant working conditions for clinical ethics support. (shrink)

Background: Clinical ethics support instruments aim to support healthcare professionals in dealing with moral challenges in clinical practice. CURA is a relatively new instrument tailored to the wishes and needs of healthcare professionals in palliative care, especially nurses. It aims to foster their moral resilience and moral competences. Aim: To investigate the effects of using CURA on healthcare professionals regarding their Moral Resilience and Moral Competences. Design: Single group pre-/post-test design with two questionnaires. Methods: Questionnaires used were the Rushton Moral (...) Resilience Scale measuring Moral Resilience and the Euro-MCD, measuring Moral Competences. Respondents mainly consisted of nurses and nurse assistants who used CURA in daily practice. Forty-seven respondents contributed to both pre- and post-test with 18 months between both tests. Analysis was done using descriptive statistics and Wilcoxon signed rank tests. This study followed the SQUIRE checklist. Ethical considerations: This study was approved by the Institutional Review Board of Amsterdam UMC. Informed consent was obtained from all respondents. Results: The total Moral Resilience score and the scores of two subscales of the RMRS, that is, Responses to Moral Adversity and Relational Integrity, increased significantly. All subscales of the Euro-MCD increased significantly at posttest. Using CURA more often did not lead to significant higher scores on most (sub) scales. Conclusion: This study indicates that CURA can be used to foster moral resilience and moral competences of healthcare professionals. CURA therefore is a promising instrument to support healthcare professionals in dealing with moral challenges in everyday practice. (shrink)

Clinical ethics support, in particular Moral Case Deliberation, aims to support health care providers to manage ethically difficult situations. However, there is a lack of evaluation instruments regarding outcomes of clinical ethics support in general and regarding Moral Case Deliberation (MCD) in particular. There also is a lack of clarity and consensuses regarding which MCD outcomes are beneficial. In addition, MCD outcomes might be context-sensitive. Against this background, there is a need for a standardised but flexible outcome evaluation instrument. The (...) aim of this study was to develop a multi-contextual evaluation instrument measuring health care providers’ experiences and perceived importance of outcomes of Moral Case Deliberation. (shrink)

Background:Clinical ethics committees have been broadly implemented in university hospitals, general hospitals and nursing homes. To ensure the quality of ethics consultations, evaluation should be...

Evaluating clinical ethics support services has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS. In this paper, we argue that a first necessary step for progress is to better understand the intervention in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a first step, we (...) introduce principles of “complex intervention research” and show how CESS fulfil the criteria of “complex interventions”. In a second step, we develop a generic “conceptual framework” for “ethics consultation on request” as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of “bioethics mediation” to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: “proactive ethics consultation” and “moral case deliberation” and discuss implications for evaluating both types of CESS. To make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer “good” CESS. (shrink)

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they (...) are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a “bottom-up” perspective might give healthcare personnel opportunities to think and reflect more than a “top-down” perspective. A “bottom-up” approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a “top-down” approach risks removing such moral responsibility. (shrink)

We congratulate Pearlman and colleagues (2016) on their detailed account of the development of a quality assessment tool for clinical ethics consultation (CEC), based on the evaluation of written r...

Background Research on the impact of ethics reflection groups (ERG) (also called moral case deliberations (MCD)) is complex and scarce. Within a larger study, two years of ERG sessions have been used as an intervention to stimulate ethical reflection about the use of coercive measures. We studied changes in: employees’ attitudes regarding the use of coercion, team competence, user involvement, team cooperation and the handling of disagreement in teams. Methods We used panel data in a longitudinal design study to measure (...) variation in survey scores from multidisciplinary employees from seven departments within three Norwegian mental health care institutions at three time points (T0–T1–T2). Mixed models were used to account for dependence of data in persons who participated more than once. Results In total, 1068 surveys (from 817 employees who did and did not participate in ERG) were included in the analyses. Of these, 7.6% (N = 62) responded at three points in time, 15.5% (N = 127) at two points, and 76.8% (N = 628) once. On average, over time, respondents who participated in ERG viewed coercion more strongly as offending (p < 0.05). Those who presented a case in the ERG sessions showed lower scores on User Involvement (p < 0.001), Team Cooperation (p < 0.01) and Constructive Disagreement (p < 0.01). We observed significant differences in outcomes between individuals from different departments, as well as between different professions. Initial significant changes due to frequency of participation in ERG and case presentation in ERG did not remain statistically significant after adjustment for Departments and Professions. Differences were generally small in absolute terms, possibly due to the low amount of longitudinal data. Conclusions This study measured specific intervention-related outcome parameters for describing the impact of clinical ethics support (CES). Structural implementation of ERGs or MCDs seems to contribute to employees reporting a more critical attitude towards coercion. Ethics support is a complex intervention and studying changes over time is complex in itself. Several recommendations for strengthening the outcomes of future CES evaluation studies are discussed. CES evaluation studies are important, since—despite the intrinsic value of participating in ERG or MCD—CES inherently aims, and should aim, at improving clinical practices. (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)

BackgroundExisting clinical ethics support (CES) instruments are considered useful. However, users report obstacles in using them in daily practice. Including end users and other stakeholders in developing CES instruments might help to overcome these limitations. This study describes the development process of a new ethics support instrument called CURA, a low-threshold four-step instrument focused on nurses and nurse assistants working in palliative care. MethodWe used a participatory development design. We worked together with stakeholders in a Community of Practice throughout the (...) study. Potential end users (nurses and nurse assistants in palliative care) used CURA in several pilots and provided us with feedback which we used to improve CURA.ResultsWe distinguished three phases in the development process. Phase one, Identifying Needs, focused on identifying stakeholder and end user needs and preferences, learning from existing CES instruments, their development and evaluation, and identify gaps. Phase two, Development, focused on designing, developing, refining and tailoring the instrument on the basis of iterative co-creation. Phase three, Dissemination, focused on implementation and dissemination. The instrument, CURA, is a four-step low-threshold instrument that fosters ethical reflection.ConclusionsParticipatory development is a valuable approach for developing clinical ethics support instruments. Collaborating with end users and other stakeholders in our development study has helped to meet the needs and preferences of end users, to come up with strategies to refine the instrument in order to enhance its feasibility, and to overcome reported limitations of existing clinical ethics instruments. (shrink)

ObjectivesTo explore the objectives and outcomes most appropriate for evaluating clinical ethics support services (CESs) in the USA.MethodsA three-round e-Delphi was sent to two professional medical ethics listservs (Medical College of Wisconsin-Bioethics and American Society for Bioethics and Humanities) as well as 19 individual experts. The survey originally contained 15 objectives and 9 outcomes. In round 1, participants were asked to validate the content of these lists. In round 2, we had 17 objectives and 10 outcomes, and participants were asked (...) to rank them for appropriateness in a top 10 list of objectives and a top 5 list of outcomes.ResultsParticipants came to a high(at least 70%) level of agreement on seven objectives: mediate, educate, develop policy, improve the moral quality of a decision or action, counsel, create a moral space and manage moral distress. Participants came to a moderate (at least 51%) level of agreement on three objectives: empower, awareness of ethics and preventative ethics. Participants also came to a moderate (at least 51%) level of agreement on five outcomes: ethical justification, transformation of institution, improvement of quality of life, principled consensus and satisfaction with the expertise of a CES.ConclusionThis e-Delphi identified 10 objectives and 5 outcomes that are a good starting point for developing outcome measures to evaluate CESs in the USA, while reminding us of the diversity of perspectives still evident in the field. (shrink)

This paper provides a series of reflections on making the case to senior leaders for the introduction of clinical ethics support services within a UK hospital Trust at a time when clinical ethics committees are dwindling in the UK. The paper provides key considerations for those building a case for clinical ethics support within hospitals by drawing upon published academic literature, and key reports from governmental and professional bodies. We also include extracts from documents relating to, and annual reports of, (...) existing clinical ethics support within UK hospitals, as well as extracts from our own proposal submitted to the Trust Board. We aim for this paper to support other ethicists and/or health care staff contemplating introducing clinical ethics support into hospitals, to facilitate the process of making the case for clinical ethics support, and to contribute to the key debates in the literature around clinical ethics support. We conclude that there is a real need for investment in clinical ethics in the UK in order to build the evidence base required to support the wider introduction of clinical ethics support into UK hospitals. Furthermore, our perceptions of the purpose of, and perceived needs met through, clinical ethics support needs to shift to one of hospitals investing in their staff. Finally, we raise concerns over the optional nature of clinical ethics support available to practitioners within UK hospitals. (shrink)

As euthanasia has become a widely debated issue in many Western countries, hospitals and nursing homes especially are increasingly being confronted with this ethically sensitive societal issue. The focus of this paper is how healthcare institutions can deal with euthanasia requests on an organizational level by means of a written institutional ethics policy. The general aim is to make a critical analysis whether these policies can be considered as organizational-ethical instruments that support healthcare institutions to take their institutional responsibility for (...) dealing with euthanasia requests. By means of an interpretative analysis, we conducted a process of reinterpretation of results of former Belgian empirical studies on written institutional ethics policies on euthanasia in dialogue with the existing international literature. The study findings revealed that legal regulations, ethical and care-oriented aspects strongly affected the development, the content, and the impact of written institutional ethics policies on euthanasia. Hence, these three cornerstones—law, care and ethics—constituted the basis for the empirical-based organizational-ethical framework for written institutional ethics policies on euthanasia that is presented in this paper. However, having a euthanasia policy does not automatically lead to more legal transparency, or to a more professional and ethical care practice. The study findings suggest that the development and implementation of an ethics policy on euthanasia as an organizational-ethical instrument should be considered as a dynamic process. Administrators and ethics committees must take responsibility to actively create an ethical climate supporting care providers who have to deal with ethical dilemmas in their practice. (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)

Law’s processes are likely always to be needed when particularly intractable conflicts arise in relation to the care of a critically ill child like Charlie Gard. Recourse to law has its merits, but it also imposes costs, and the courts’ decisions about the best interests of such children appear to suffer from uncertainty, unpredictability and insufficiency. The insufficiency arises from the courts’ apparent reluctance to enter into the ethical dimensions of such cases. Presuming that such reflection is warranted, this article (...) explores alternatives to the courts, and in particular the merits of specialist ethics support services, which appear to be on the rise in the UK. Such specialist services show promise, as they are less formal and adversarial than the courts and they appear capable of offering expert ethical advice. However, further research is needed into such services – and into generalist ethics support services – in order to gauge whether this is indeed a promising development. (shrink)

A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into (...) moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded ‘grey zone articles’, in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients’ and caregivers’ views on ethical challenges, is presented. (shrink)

BackgroundClinical ethics support aims to support health care professionals in dealing with ethical issues in clinical practice. Although the prevalence of CES is increasing, it does meet challenges and pressing questions regarding implementation and organization. In this paper we present a specific way of organizing CES, which we have called integrative CES, and argue that this approach meets some of the challenges regarding implementation and organization.MethodsThis integrative approach was developed in an iterative process, combining actual experiences in a case study (...) in which we offered CES to a team that provides transgender health care and reflecting on the theoretical underpinnings of our work stemming from pragmatism, hermeneutics and organizational and educational sciences.ResultsIn this paper we describe five key characteristics of an integrative approach to CES; 1. Positioning CES more within care practices, 2. Involving new perspectives, 3. Creating co-ownership of CES, 4. Paying attention to follow up, and 5. Developing innovative CES activities through an emerging design.ConclusionsIn the discussion we compare this approach to the integrated approach to CES developed in the US and the hub and spokes strategy developed in Canada. Furthermore, we reflect on how an integrative approach to CES can help to handle some of the challenges of current CES. (shrink)

Clinical ethics support for health care professionals and patients is increasingly seen as part of good health care. However, there is a key drawback to the way CES services are currently offered. They are often performed as isolated and one-off services whose ownership and impact are unclear. This paper describes the development of an integrative approach to CES at the Center of Expertise and Care for Gender Dysphoria at Amsterdam University Medical Center. We specifically aimed to integrate CES into daily (...) work processes at the CEGD. In this paper, we describe the CES services offered there in detail and elaborate on the 16 lessons we learned from the process of developing an integrative approach to CES. These learning points can inform and inspire CES professionals, who wish to bring about greater integration of CES services into clinical practice. (shrink)

Clinical ethics support for health care professionals and patients is increasingly seen as part of good health care. However, there is a key drawback to the way CES services are currently offered. They are often performed as isolated and one-off services whose ownership and impact are unclear. This paper describes the development of an integrative approach to CES at the Center of Expertise and Care for Gender Dysphoria at Amsterdam University Medical Center. We specifically aimed to integrate CES into daily (...) work processes at the CEGD. In this paper, we describe the CES services offered there in detail and elaborate on the 16 lessons we learned from the process of developing an integrative approach to CES. These learning points can inform and inspire CES professionals, who wish to bring about greater integration of CES services into clinical practice. (shrink)

The prevalence of Clinical ethics support services is increasing. Yet, questions about what quality of CES entails and how to foster the quality of CES remain. This paper describes the development of a national network, which aimed to conceptualize and foster the quality of CES in the Netherlands simultaneously. Our methodology was inspired by a responsive evaluation approach which shares some of our key theoretical presuppositions of CES. A responsive evaluation methodology engages stakeholders in developing quality standards of a certain (...) practice, instead of evaluating a practice by predefined standards. In this paper, we describe the relationship between our theoretical viewpoint on CES and a responsive evaluation methodology. Then we describe the development of the network and focus on three activities that exemplify our approach. In the discussion, we reflect on the similarities and differences between our approach and other international initiatives focusing on the quality of CES. (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)

In their recent work, Kok et al propose a theoretical framework for the evaluation of clinical ethical case interventions, in particular moral case deliberation (MCD).1 According to the authors, this framework provides ‘empirically accessible hypothesis that describe the relationship between MCD and care quality at the organisational level’.1 Evaluation of ethical interventions in healthcare is an important topic. As Donabedian has noted, evaluation can be understood as defining reasonable quality expectations and to check by means of empirical research whether and (...) to what extent these expectations have been met.2 If suitable for ethical interventions like MCDs, the carefully compiled framework by Kok et al would surely present a major step towards satisfying the requirements outlined by Donabedian. However, caution is in order whether this holds true. The authors start by observing that most of the recent research regarding the evaluation of MCD tends to follow a paradigm that can be outlined by two premises. First, focusing on quality is justified by the need to provide a rationale for an intervention’s consumption of resources.3 Second, this implies research that is usually centred around the quality …. (shrink)

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

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 (CES) 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 (Euro-MCD) was developed to measure outcomes of Moral Case Deliberation (MCD). 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 (e.g. ‘now’) instead of an assumed improvement over time (e.g. ‘better’) 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)