Perspective; recommendations for improved patient participation in decision-making for geriatric patients in acute surgical settings.

Geriatric patients often present to the hospital in acute surgical settings. In these settings, shared decision-making as equal partners can be challenging. Surgeons should recognize that geriatric patients, and frail patients in particular, may sometimes benefit from de-escalation of care in a palliative setting rather than curative treatment. To provide more person-centred care, better strategies for improved shared decision-making need to be developed and implemented in clinical practice. A shift in thinking from a disease-oriented paradigm to a patient-goal-oriented paradigm is required to provide better person-centred care for older patients. We may greatly improve the collaboration with patients if we move parts of the decision-making process to the pre-acute phase. In the pre-acute phase appointing legal representatives, having goals of care conversations, and advance care planning can help give physicians an idea of what is important to the patient in acute settings. When making decisions as equal partners is not possible, a greater degree of physician responsibility may be appropriate. Physicians should tailor the "sharedness" of the decision-making process to the needs of the patient and their family.

[Heart donation after circulatory death: ethical and emotional aspect of central normothermic regional perfusion]. / Hoe behoud je een donorhart na circulatoir overlijden?

Heart transplantation after circulatory death is possible in different countries with the use of ex situ normothermic perfusion of the donor heart. Central normothermic regional perfusion, where the circulation in the donor is restarted using an extracorporeal life support system after circulatory death, may give a better 1-years survival and a reduction in costs compared to ex situ normothermic perfusion of the donor heart. However, restarting circulation in a donor that was just declared death by circulatory criteria may be controversial. The advantages described are, in our view, reason to consider central normothermic regional perfusion, in which case a debate on ethical and emotional aspects is of great importance. In this article, we describe two point of views and hope in this way to start the debate on central normothermic regional perfusion in the Netherlands.

[Dealing with treatment limitations during anaesthesia]. / Omgaan met behandelgrenzen tijdens anesthesie.

Treatment limitations may create a clinical dilemma during anaesthesia. Because mostly, pre-existing treatment limitations have been decided upon without considering the occurrence of a future medical intervention with its unique circumstances. In case treatment limitations are not reassessed prior to an intervention and a life threatening situation occurs during the intervention, a dilemma may arise between the patient's wishes and physician's actions. For example, overtreatment may occur when treatment limitations are ignored during an intervention without the patient's consent. Or undertreatment may occur if a physician strictly adheres to the treatment limitations without taking the situation of an intervention into account. So, how do we respect a patient's autonomy while striving to provide acute care in the patient's best interests? We suggest (re)considering treatment limitations under anaesthesia with every patient with pre-existing limitations, and ideally, with every fragile patient, prior to an intervention.

[The patient voice in psychiatry: not heard, co-creation, co-optation or parallel organisation?] / De stem van de patiënt in de psychiatrie: niet gehoord, cocreatie, coöptatie of parallelle organisatie?

BACKGROUND: A key ethical issue in psychiatry concerns the relationship with patients. A central dilemma is that experiential knowledge (regarding existential recovery) and professional knowledge (the framework of specific-medication-for-specific-brain-disorder) are not easily integrated into a practice of co-creation. AIM: To describe the status quo in health care and science. METHOD: Qualitative review. RESULTS: Under the influence of critical psychiatry ('antipsychiatry'), the recovery movement, the voice hearing movement and open science, the patient voice has gained influence while the scientific framework of academic psychiatry/psychology is critically re-examined. Co-creation in mental health services is limited whilst parallel development is more successful. For example, experience-based recovery academies are developing primarily in the domain of social care whilst evidence-based specialist treatment remains the norm in mental health services. There is, however, a growing call for co-creation around recovery-oriented work in the mental health sector, despite limited institutional readiness. There is also a growing movement of user research responding to epistemic injustice and driving patient-driven innovations - although sometimes on the basis of appropriation without source awareness. CONCLUSION: Experiential knowledge is growing as the theoretical framework of psychiatry is in the process of change. This creates the conditions for co-creation of a new values-driven psychiatry.

Unraveling patients' readiness in advance care planning conversations: a qualitative study as part of the ACTION Study.

PURPOSE: Patients' readiness for advance care planning (ACP) is often considered a prerequisite for starting ACP conversations. Healthcare professionals' uncertainty about patients' readiness hampers the uptake of ACP in clinical practice. This study aims To determine how patients' readiness is expressed and develops throughout an ACP conversation. METHODS: A qualitative sub-study into the ACTION ACP conversations collected as part of the international Phase III multicenter cluster-randomized clinical trial. A purposeful sample was taken of ACP conversations of patients with advanced lung or colorectal cancer who participated in the ACTION study between May 2015 and December 2018 (n = 15). A content analysis of the ACP conversations was conducted. RESULTS: All patients (n = 15) expressed both signs of not being ready and of being ready. Signs of being ready included anticipating possible future scenarios or demonstrating an understanding of one's disease. Signs of not being ready included limiting one's perspective to the here and now or indicating a preference not to talk about an ACP topic. Signs of not being ready occurred more often when future-oriented topics were discussed. Despite showing signs of not being ready, patients were able to continue the conversation when a new topic was introduced. CONCLUSION: Healthcare professionals should be aware that patients do not have to be ready for all ACP topics to be able to participate in an ACP conversation. They should be sensitive to signs of not being ready and develop the ability to adapt the conversation accordingly.

Content analysis of Advance Directives completed by patients with advanced cancer as part of an Advance Care Planning intervention: insights gained from the ACTION trial.

PURPOSE: Writing an Advance Directive (AD) is often seen as a part of Advance Care Planning (ACP). ADs may include specific preferences regarding future care and treatment and information that provides a context for healthcare professionals and relatives in case they have to make decisions for the patient. The aim of this study was to get insight into the content of ADs as completed by patients with advanced cancer who participated in ACP conversations. METHODS: A mixed methods study involving content analysis and descriptive statistics was used to describe the content of completed My Preferences forms, an AD used in the intervention arm of the ACTION trial, testing the effectiveness of the ACTION Respecting Choices ACP intervention. RESULTS: In total, 33% of 442 patients who received the ACTION RC ACP intervention completed a My Preferences form. Document completion varied per country: 10.4% (United Kingdom), 20.6% (Denmark), 29.2% (Belgium), 41.7% (the Netherlands), 61.3% (Italy) and 63.9% (Slovenia). Content analysis showed that 'maintaining normal life' and 'experiencing meaningful relationships' were important for patients to live well. Fears and worries mainly concerned disease progression, pain or becoming dependent. Patients hoped for prolongation of life and to be looked after by healthcare professionals. Most patients preferred to be resuscitated and 44% of the patients expressed maximizing comfort as their goal of future care. Most patients preferred 'home' as final place of care. CONCLUSIONS: My Preferences forms provide some insights into patients' perspectives and preferences. However, understanding the reasoning behind preferences requires conversations with patients.

Trained facilitators' experiences with structured advance care planning conversations in oncology: an international focus group study within the ACTION trial.

BACKGROUND: In oncology, Health Care Professionals often experience conducting Advance Care Planning (ACP) conversations as difficult and are hesitant to start them. A structured approach could help to overcome this. In the ACTION trial, a Phase III multi-center cluster-randomized clinical trial in six European countries (Belgium, Denmark, Italy, the Netherlands, Slovenia, United Kingdom), patients with advanced lung or colorectal cancer are invited to have one or two structured ACP conversations with a trained facilitator. It is unclear how trained facilitators experience conducting structured ACP conversations. This study aims to understand how facilitators experience delivering the ACTION Respecting Choices (RC) ACP conversation. METHODS: A qualitative study involving focus groups with RC facilitators. Focus group interviews were recorded, transcribed, anonymized, translated into English, and thematically analysed, supported by NVivo 11. The international research team was involved in data analysis from initial coding and discussion towards final themes. RESULTS: Seven focus groups were conducted, involving 28 of in total 39 trained facilitators, with different professional backgrounds from all participating countries. Alongside some cultural differences, six themes were identified. These reflect that most facilitators welcomed the opportunity to participate in the ACTION trial, seeing it as a means of learning new skills in an important area. The RC script was seen as supportive to ask questions, including those perceived as difficult to ask, but was also experienced as a barrier to a spontaneous conversation. Facilitators noticed that most patients were positive about their ACTION RC ACP conversation, which had prompted them to become aware of their wishes and to share these with others. The facilitators observed that it took patients substantial effort to have these conversations. In response, facilitators took responsibility for enabling patients to experience a conversation from which they could benefit. Facilitators emphasized the need for training, support and advanced communication skills to be able to work with the script. CONCLUSIONS: Facilitators experienced benefits and challenges in conducting scripted ACP conversations. They mentioned the importance of being skilled and experienced in carrying out ACP conversations in order to be able to explore the patients' preferences while staying attuned to patients' needs. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number registry 63110516 ( ISRCTN63110516 ) per 10/3/2014.

[The option of non-treatment as part of end-of-life care]. / Doorbehandelen tot de dood erop volgt?

In this article we describe the story of a patient who died aged 63 as a result of pancreatic cancer. In the 14 weeks between diagnosis and passing away, at no point was it discussed whether treatment was in the patient's interest at such an advanced stage of the disease. The topic of death was not broached either. We wish to encourage doctors to consider a treatment option that seems to be a delicate topic of conversation for both doctor and patient: the option of non-treatment. It is necessary for doctors to make end-of-life discussions less daunting. The art of medicine does not necessarily consist of following a protocol; rather, the medical knowledge contained in that protocol should be drawn from, in order to serve the patient's objectives.

Narrative medicine as a medical education tool: A systematic review.

Aim: Narrative medicine has been promoted as an innovative and effective means of stimulating medical students' professional development by teaching them to approach their patients' experiences of illness with more understanding and compassion. This systematic literature review aims to answer the following question: what evidence of effect is available in the literature about models for teaching narrative medicine? Methods: We conducted a narrative review of 36 articles and used the Best Evidence in Medical Education (BEME) Global Scale and Kirkpatrick Scale for strength and importance of evidence to categorize reported assessment strategies and to evaluate the effectiveness of their narrative medicine programs. Results: We found evidence that narrative medicine is an effective pedagogic tool with a clear and replicable structure and methodology. We also determined that a positive impact could be measured when pertaining to participation and modification of attitudes, knowledge, and skills. However, unequivocal evidence of the effect of narrative medicine on students' behavior or ongoing interaction with colleagues and patients is still lacking. Conclusion: While many recent publications describe the goals and virtues of a narrative-based approach, more research is needed to determine whether or not there is an ideological consensus undergirding this approach. In addition, it is still unclear whether the long-term impact of narrative medicine classroom interventions are felt by patients, or whether such interventions positively impact patient care.

[Euthanasia of Dutch psychiatric patients in 2015-2017]. / Euthanasie van Nederlandse psychiatrische patiënten in 2015-2017.

BACKGROUND: The Netherlands is one of the few countries in the world that allows euthanasia and assisted suicide (EAS) due to psychiatric suffering. METHODS In 2015-2017 the Dutch regional euthanasia review committees published 43 case summaries online. Of these, 35 were suitable for analysis regarding patient characteristics and physician involvement, and 3 cases were described in detail.
RESULTS: In total, 77% of the patients were women and 51% were aged 50-70 years. Major depression disorder and personality disorders were present in almost half of the patients. All patients were considered mentally competent. CONCLUSIONS Although the incidence of psychiatric EAS cases is rising, we found no shift in patient characteristics. The division between psychiatric and somatic suffering may prove more complicated than expected. Patients dying from suicide differ in various ways from patients dying through EAS. The fact that all patients are considered competent could mean that they are unjustly seen as being vulnerable or that the competence assessment lacks due diligence.

Responsible data sharing in a big data-driven translational research platform: lessons learned.

BACKGROUND: To foster responsible data sharing in health research, ethical governance complementary to the EU General Data Protection Regulation is necessary. A governance framework for Big Data-driven research platforms will at least need to consider the conditions as specified a priori for individual datasets. We aim to identify and analyze these conditions for the Innovative Medicines Initiative's (IMI) BigData@Heart platform. METHODS: We performed a unique descriptive case study into the conditions for data sharing as specified for datasets participating in BigData@Heart. Principle investigators of 56 participating databases were contacted via e-mail with the request to send any kind of documentation that possibly specified the conditions for data sharing. Documents were qualitatively reviewed for conditions pertaining to data sharing and data access. RESULTS: Qualitative content analysis of 55 relevant documents revealed overlap on the conditions: (1) only to share health data for scientific research, (2) in anonymized/coded form, (3) after approval from a designated review committee, and while (4) observing all appropriate measures for data security and in compliance with the applicable laws and regulations. CONCLUSIONS: Despite considerable overlap, prespecified conditions give rise to challenges for data sharing. At the same time, these challenges inform our thinking about the design of an ethical governance framework for data sharing platforms. We urge current data sharing initiatives to concentrate on: (1) the scope of the research questions that may be addressed, (2) how to deal with varying levels of de-identification, (3) determining when and how review committees should come into play, (4) align what policies and regulations mean by "data sharing" and (5) how to deal with datasets that have no system in place for data sharing.

Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports.

BACKGROUND: Within the EU, regulators are obliged to take ethical issues into consideration during marketing authorization deliberation. The goal of this manuscript is to identify what kinds of ethical issues regulators encounter during marketing authorization application deliberations, and the incidence of these ethical issues. METHODS: This study used an EMA-provided Excel file that contains all the GCP non-compliance findings from all inspection reports from 2008-2012. There were 112 medicinal products and a total of 288 clinical trial sites. There were a total of 4014 GCP non-compliance findings. The findings that were ethically relevant were extracted using NVivo 10.0 and categories for the ethically relevant findings (ERFs) were created. Note was taken of the incidence of ERFs for each category and the inspectors' gradings of these findings were extracted. This study also looked at the mean and the maximum number of ERFs per grading per medicinal product application, as well as the number of medicinal products with at least one ERF and those with at least major ERFs. RESULTS: With multiple coding, there were 1685 ERFs. ERFs were present in almost all of the medicinal products (97.3%). The majority of ERFs were graded as major. At least major ERFs were present in almost all medicinal products with ERFs. The categories with the highest number of ERFs were protocol issues, patient safety, and professionalism issues. In terms of the density of combined critical and major findings, monitoring and oversight, protocol issues, and respect for persons top the list. This study also showed that, on average, there were 7.54 major and 2.95 critical ERFs per medicinal product application, although ERFs can increase to 30 major and 12 critical. CONCLUSION: Regulators regularly encounter ERFs that at least "might adversely affect the rights, safety or well-being of the subjects". It remains to be explored how regulators respond to these ethical issues.

Ethics in musculoskeletal regenerative medicine; guidance in choosing the appropriate comparator in clinical trials.

BACKGROUND: Regenerative Medicine (RM) techniques aimed at the musculoskeletal system are increasingly translated to clinical trials and patient care. This revolutionary era in science raises novel ethical challenges. One of these challenges concerns the appropriate choice of the comparator in (randomized controlled) trials, including the ethically contentious use of sham procedures. To date, only general guidelines regarding the choice of the comparator exist. OBJECTIVE: To provide specific guidelines for clinical trial comparator choice in musculoskeletal RM. METHODS: In this manuscript, we discuss the ethics of comparator selection in RM trials. First, we make a classification of RM interventions according to different health states from disease prevention, return to normal health, postponing RM treatment, supplementing RM treatment, substituting RM treatment, improving RM outcome, and slowing progression. Subsequently, per objective, the accompanying ethical points to consider are evaluated with support from the available literature. RESULTS: a sham procedure is demonstrated to be an ethically acceptable comparator in RM trials with certain objectives, but less appropriate for musculoskeletal RM interventions that aim at preventing disease or substituting a surgical treatment. The latter may be compared to 'standard of care'. CONCLUSION: From a scientific perspective, choosing the correct comparator based on ethical guidelines is a step forward in the success of musculoskeletal RM.

Privacy in Big Data psychiatric and behavioural research: A multiple-case study.

In Big Data health research, concerns have risen about privacy and data protection. While the ethical and legal discussion about these issues is ongoing, so is research practice. The aim of this qualitative case study is to gain more insight into how these concerns are currently dealt with in practice. For this multiple-case study, the YOUth cohort, a longitudinal cohort focusing on psychosocial development, and Big Data Psychiatry, a pilot study in Big Data analytics on psychiatric health data, were selected. A broad range of relevant documents were collected and semi-structured interviews with stakeholders were conducted. Data were coded, studied and divided into themes during an iterative analytical process. Three themes emerged: abandoning anonymisation, reconfiguring participant control, and the search for guidance and expertise. Overall, the findings show that it takes considerable effort to take privacy and data protection norms into account in a Big Data health research initiative, especially when individual participant level data need to be linked or enriched. By embracing the complexity of the law in an early phase, setbacks could be prevented, the existing flexibility within the law could be utilised, and systems or organisations could be designed and constructed to take relevant rules into account. Our paper illustrates that a close collaboration of experts with different backgrounds within the initiative may be necessary to be able to successfully navigate this process.

[The objective of advance care planning]. / Het doel van 'advance care planning'.

This commentary reflects on a study to determine the efficacy of an advance care planning (ACP) website in increasing planning documentation. It is interesting to see that ACP is considered to be a regular intervention. ACP thus ceases to be something to believe in or not and becomes a normal intervention, the efficacy of which can be studied. The study also shows that ACP is a concept which can take many forms, that ACP in itself is almost an umbrella term and that physicians need not take the central role in ACP. The main point of critique of the study, however, is that the endpoint of the study is documentation. One can question whether that is the right objective of ACP as the worth of ACP would seem to lie more in the process of enabling a patient to reflect on treatment goals and personal values than in writing a living will.