Restraint in somatic healthcare: how should it be regulated?

Restraint is regularly used in somatic healthcare settings, and countries have chosen different paths to regulate restraint in somatic healthcare. One overarching problem when regulating restraint is to ensure that patients with reduced decision-making capacity receive the care they need and at the same time ensure that patients with a sufficient degree of decision-making capacity are not forced into care that they do not want. Here, arguments of justice, trust in the healthcare system, minimising harm and respecting autonomy are contrasted with different national regulations. We conclude that a regulation that incorporates an assessment of patients' decision-making capacity and considers the patient's best interests is preferable, in contrast to regulations based on psychiatric diagnoses or regulations where there are no legal possibilities to exercise restraint at all in somatic care.

Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses' experiences.

BACKGROUND: Clinical research nurses (CRNs) have first-hand experience with ethical challenges and play a crucial role in upholding ethical conduct and adherence to the principles of informed consent in clinical research. This study explores the ethical challenges encountered by CRNs in the process of obtaining informed consent for clinical research. METHODS: A qualitative exploratory design. Semistructured interviews (n = 14) were conducted with diverse CRNs in Sweden. These CRNs covered a wide range of research fields, including pharmaceutical and academic studies, interventions, and observational research, spanning different trial phases, patient categories, and medical conditions. The interviews were analysed using inductive qualitative content analysis. RESULTS: The analysis identified three main categories: (i) threats to voluntariness, (ii) measures to safeguard voluntariness, and (iii) questionable exclusion of certain groups. CRNs face challenges due to time constraints, rushed decisions, information overload, and excessive reliance on physicians' recommendations. Overestimating therapeutic benefits in stages of advanced illness emerged as a risk to voluntariness. CRNs outlined proactive solutions, such as allowing ample decision-making time and offering support, especially for terminally ill patients. Concerns were also voiced about excluding certain demographics, such as those with language barriers or cognitive impairments. CONCLUSIONS: In conclusion, upholding ethical research standards requires recognising various factors affecting patient voluntariness. Researchers and CRNs should prioritise refining the informed consent process, overcoming participation challenges, and aligning scientific rigour with personalised care. Additionally, a concerted effort is vital to meet the diverse needs of patient populations, including equitable inclusion of individuals with language barriers or cognitive limitations in clinical studies. These findings have significant implications for enhancing the ethics of clinical research and advancing person-centred care.

"Being prevented from providing good care: a conceptual analysis of moral stress among health care workers during the COVID-19 pandemic".

BACKGROUND: Health care workers (HCWs) are susceptible to moral stress and distress when they are faced with morally challenging situations where it is difficult to act in line with their moral standards. In times of crisis, such as disasters and pandemics, morally challenging situations are more frequent, due to the increased imbalance between patient needs and resources. However, the concepts of moral stress and distress vary and there is unclarity regarding the definitions used in the literature. This study aims to map and analyze the descriptions used by HCWs regarding morally challenging situations (moral stress) and refine a definition through conceptual analysis. METHODS: Qualitative data were collected in a survey of 16,044 Swedish HCWs who attended a COVID-19 online course in autumn 2020. In total, 643 free-text answers with descriptions of moral stress were analyzed through content analysis. RESULTS: Three themes emerged from the content analysis (1) "Seeing, but being prevented to act; feeling insufficient/inadequate and constrained in the profession," (2) "Someone or something hindered me; organizational structures as an obstacle," and (3) "The pandemic hindered us; pandemic-related obstacles." The three themes correspond to the main theme, "Being prevented from providing good care." DISCUSSION: The main theme describes moral stress as various obstacles to providing good care to patients in need and acting upon empathic ability within the professional role. The themes are discussed in relation to established definitions of moral stress and are assessed through conceptual analysis. A definition of moral stress was refined, based on one of the established definitions. CONCLUSIONS: On the basis of the study results and conceptual analysis, it is argued that the presented definition fulfils certain conditions of adequacy. It is essential to frame the concept of moral stress, which has been defined in different ways in different disciplines, in order to know what we are talking about and move forward in developing prevention measures for the negative outcomes of this phenomenon.

Should relational effects be considered in health care priority setting?

It is uncontroversial to claim that the extent to which health care interventions benefit patients is a relevant consideration for health care priority setting. However, when effects accrue to the individual patient, effects of a more indirect kind may accrue to other individuals as well, such as the patient's children, friends, or partner. If, and if so how, such relational effects should be considered relevant in priority setting is contentious. In this paper, we illustrate this question by using disease-modifying drugs for Alzheimer's disease as a case in point. The ethical analysis begins by sketching the so-called prima facie case for ascribing moral weight to relational effects and then moves on to consider a number of objections to it. We argue that, whereas one set of objections may be dismissed, there is another set of arguments that poses more serious challenges for including relational effects in priority setting.

Patients with borderline personality disorder and the effects of compulsory admissions on self-harm behaviour: a questionnaire study.

BACKGROUND: Previous research on patients with borderline personality disorder (BPD) has indicated negative effects, including increased suicidality, from long hospital admissions and paternalism. Still, long-term compulsory admissions have been reported to occur regularly. Less is known about how healthcare personnel perceives these admissions and to what extent they think the use of compulsory care can be diminished. This study addresses those questions to make care more beneficial. METHODS: A questionnaire study, the respondents being nurses and psychiatric aides employed at psychiatric hospital wards in Sweden. The questionnaire contained questions with fixed answers and room for comments. 422 questionnaires were distributed to 21 wards across Sweden, and the response rate was 66%. The data were analysed with descriptive statistics and qualitative descriptive content analysis. RESULTS: Most respondents experienced that more than a week's compulsory admission either increased (68%) or had no effect (26%) on self-harm behaviour. A majority (69%) considered the compulsory admissions to be too long at their wards, with detrimental effects on the patients. They also recognized several reasons for compulsory admissions without medical indication, like doctors' fear of complaints and patients' lack of housing. Also, patients sometimes demand compulsory care. Respondents recommended goal-oriented care planning, around three-day-long voluntary admissions, and better outpatient care to reduce compulsory hospital admissions. DISCUSSION: These findings imply that many BPD patients are regularly forced to receive psychiatric care that inadvertently can make them self-harm more. The respondents' comments can be used as a source when formulating clinical guidelines.

Understanding nurses' justification of restraint in a neurosurgical setting: A qualitative interview study.

BACKGROUND: Despite its negative impact on patients and nurses, the use of restraint in somatic health care continues in many settings. Understanding the reasons and justifications for the use of restraint among nurses is crucial in order to manage this challenge. AIM: To understand nurses' justifications for restraint use in neurosurgical care. RESEARCH DESIGN: A qualitative, descriptive design was used. Data were analysed with inductive qualitative content analysis. PARTICIPANTS AND RESEARCH CONTEXT: Semi-structured interviews with 15 nurses working in three neurosurgical departments in Sweden. ETHICAL CONSIDERATIONS: Approved by The Regional Ethics Committee, Stockholm, Sweden. FINDINGS: The analysis resulted in three categories. The category Patient factors influencing restraint use describes patient factors that trigger restraint, such as a diminished decision-making competence, restlessness, and need for invasive devices. The category Specific reasons for justifying restraint describes reasons for restraining patients, such as restraint being used for the sake of the patient or for the sake of others. The category General reasoning in justifying restraint describes how nurses reason when using restraint, and the decision to use restraint was often based on a consequentialist approach where the nurses' weighed the pros and cons of different alternatives. DISCUSSION: Nurses with experience of restraint use were engaged in a constant process of justifying and balancing different options and actions. Restraint was considered legitimate if the benefit exceeded the suffering, but decisions on which restraint measures to use and when to use them depended on the values of the individual nurse. CONCLUSION: How nurses reason when justifying restraint, why they use restraint, and who they use restraint on must be considered when creating programs and guidelines to reduce the use of restraint and to ensure that when it is used it is used carefully, appropriately, and with respect.

Rawlsian reasoning about fairness at the end of life.

OBJECTIVES: The aim of this study was to discuss end-of-life care in the context of Rawls' and Daniels' philosophy of justice. The study is based on an empirical survey of Swedish physicians who were asked whether they would want the option of physician-assisted suicide (PAS) for themselves (hereafter called own preferences), what are their attitudes towards PAS in general and whether they were prepared to prescribe PAS drugs to eligible patients. The question is to what extent the physicians' answers are impartial and consistent in a Rawlsian sense. METHODS: The underlying indicator was the physicians' own preferences. Kappa score inter-rater agreement was measured between that response and that same physician's general attitude towards allowing PAS and preparedness to prescribe PAS drugs. The coherence of provided comments and arguments were analysed using content analysis. RESULTS: Palliative care physicians are the least willing to offer PAS, and surgeons and psychiatrist the most willing. There is a discrepancy between physicians' general attitudes about allowing PAS, their own wishes to be offered PAS at the end of life and the concrete action of prescribing PAS drugs. Arguments given for not prescribing PAS by those in favour of PAS are seemingly but not truly inconsistent. CONCLUSIONS: Those supporting PAS provided impartial and consistent arguments for their stances in a Rawlsian sense, while those against PAS provided partial arguments. Two specialties, psychiatrists and palliative care physicians, were coherent in their reasoning about PAS for themselves and their willingness to prescribe the needed drugs.

Dealing with difficult choices: a qualitative study of experiences and consequences of moral challenges among disaster healthcare responders.

BACKGROUND: Disasters are chaotic events with healthcare needs that overwhelm available capacities. Disaster healthcare responders must make difficult and swift choices, e.g., regarding who and what to prioritize. Responders dealing with such challenging choices are exposed to moral stress that might develop into moral distress and affect their wellbeing. We aimed to explore how deployed international disaster healthcare responders perceive, manage and are affected by moral challenges. METHODS: Focus groups discussions were conducted with 12 participants which were Swedish nurses and physicians with international disaster healthcare experience from three agencies. The transcribed discussions were analyzed using content analysis. RESULTS: We identified five interlinked themes on what influenced perceptions of moral challenges; and how these challenges were managed and affected responders' wellbeing during and after the response. The themes were: "type of difficult situation", "managing difficult situations", "tools and support", "engagement as a protective factor", and "work environment stressors as a risk factor. Moral challenges were described as inevitable and predominant when working in disaster settings. The responders felt that their wellbeing was negatively affected depending on the type and length of their stay and further; severity, repetitiveness of encounters, and duration of the morally challenging situations. Responders had to be creative and constructive in resolving and finding their own support in such situations, as formal support was often either lacking or not considered appropriate. CONCLUSION: The participating disaster healthcare responders were self-taught to cope with both moral challenges and moral distress. We found that the difficult experiences also had perceived positive effects such as personal and professional growth and a changed worldview, although at a personal cost. Support considered useful was foremost collegial support, while psychosocial support after deployment was considered useful provided that this person had knowledge of the working conditions and/or similar experiences. Our findings may be used to inform organizations' support structures for responders before, during and after deployment.

Hospital staff at most psychiatric clinics in Stockholm experience that patients who self-harm have too long hospital stays, with ensuing detrimental effects.

BACKGROUND: Previous research on patients who self-harm has indicated potential negative effects from long hospital stays. Yet, such care has been reported to occur regularly. We conducted this questionnaire study to investigate how hospital staff, who treat self-harming patients, experience the relation between lengths of stay and self-harm behaviour, and the motives for non-beneficial hospital stays. METHODS: The respondents of the questionnaire were nurses and mental health workers employed at public inpatient wards in Stockholm, treating patients who self-harm. The questionnaire contained questions with fixed answers and room for comments. A total of 304 questionnaires were distributed to 13 wards at five clinics, and the response rate was 63%. The data were analysed with descriptive statistics and qualitative descriptive content analysis. RESULTS: The results show that most staff experienced that more than a week's stay either increased (57%) or had no effect (33%) on self-harm behaviour. Most respondents at most clinics considered the stays to be too long at their wards, and that the stays could be reduced. The respondents recognized several reasons for non-beneficial hospital stays, like fear of suicidal behaviour and doctors' fear of complaints. Patients appearing as demanding or fragile were thought to be given more care than others. The respondents' comments confirmed the majority's experience of detrimental effects from longer hospital stays. CONCLUSIONS: A majority of the health care staff experienced that patients who self-harm often receive too long hospital stays, with detrimental effects, and they had experienced several non-medical reasons for such care.

Nurses' experiences of using restraint in neurosurgical care - A qualitative interview study.

AIM AND OBJECTIVES: To describe nurses' experiences of using restraint in neurosurgical care. BACKGROUND: Despite reports of negative consequences, and conflicts with key values in healthcare, restraint measures are still practised in somatic healthcare worldwide. When using restraint, basic principles of nursing collide, creating dilemmas known to be perceived as difficult for many nurses. Patients in neurosurgical care are at high risk of being subjected to restraint, but research on nurses' experiences of using restraint in neurosurgical care are scarce. DESIGN: A qualitative, descriptive design guided by a naturalistic inquiry was used. METHODS: Semi-structured interviews with 15 nurses working in three neurosurgical departments in Sweden were analysed with inductive qualitative content analysis. COREQ reporting guidelines were used as reporting checklist. RESULTS: The analysis resulted in one overarching theme, The struggling professional, and two categories. The category Internal struggle describes nurses' conflicting emotions and internal struggle when engaging in restraint. The category The struggle in clinical practice, describes how nurses struggle with handling restraint in clinical practice, and how the use of restraint is based on individual assessment rather than guidelines. CONCLUSION: Nurses' experience restraint in neurosurgical care as a multi-layered struggle, ranging from inner doubts to practical issues. In order to enhance patient safety, there is a need for policies and guidelines regarding the use of restraint, as well as structured discussions and reflections for nurses engaged in the practice. RELEVANCE TO CLINICAL PRACTICE: The results highlight the importance of clear guidelines, openness, support and teamwork for nurses working with patients at risk to be subjected to restraint, in order to create a safer care for patients as well as healthcare personnel. When developing guidelines and policies concerning restraint in somatic care, both practical issues such as the decision-making process, and the emotional effect on nurses should be considered.

How to reveal disguised paternalism: version 2.0.

BACKGROUND: We aim to further develop an index for detecting disguised paternalism, which might influence physicians' evaluations of whether or not a patient is decision-competent at the end of life. Disguised paternalism can be actualized when physicians transform hard paternalism into soft paternalism by questioning the patient's decision-making competence. METHODS: A previously presented index, based on a cross-sectional study, was further developed to make it possible to distinguish between high and low degrees of disguised paternalism using the average index of the whole sample. We recalculated the results from a 2007 study for comparison to a new study conducted in 2020. Both studies are about physicians' attitudes towards, and arguments for or against, physician-assisted suicide. RESULTS: The 2020 study showed that geriatricians, palliativists, and middle-aged physicians (46-60 years old) had indices indicating disguised paternalism, in contrast with the results from the 2007 study, which showed that all specialties (apart from GPs and surgeons) had indices indicating high degrees of disguised paternalism. CONCLUSIONS: The proposed index for identifying disguised paternalism reflects the attitude of a group towards physician assisted suicide. The indices make it possible to compare the various medical specialties and age groups from the 2007 study with the 2020 study. Because disguised paternalism might have clinical consequences for the rights of competent patients to participate in decision-making, it is important to reveal disguised hard paternalism, which could masquerade as soft paternalism and thereby manifest in practice. Methods for improving measures of disguised paternalism are worthy of further development.

Trends in Swedish physicians' attitudes towards physician-assisted suicide: a cross-sectional study.

AIMS: To examine attitudes towards physician-assisted suicide (PAS) among physicians in Sweden and compare these with the results from a similar cross-sectional study performed in 2007. PARTICIPANTS: A random selection of 250 physicians from each of six specialties (general practice, geriatrics, internal medicine, oncology, surgery and psychiatry) and all 127 palliative care physicians in Sweden were invited to participate in this study. SETTING: A postal questionnaire commissioned by the Swedish Medical Society in collaboration with Karolinska Institute in Stockholm. RESULTS: The total response rate was 59.2%. Slightly fewer than half [47.1% (95% CI 43.7-50.5)] of the respondents from the six specialties accepted PAS, which is significantly more than accepted PAS in the 2007 study [34.9% (95% CI 31.5-38.3)]. Thirty-three percent of respondents were prepared to prescribe the needed drugs. When asked what would happen to the respondent's own trust in healthcare, a majority [67.1% (95% CI 63.9-70.3)] stated that legalizing PAS would either not influence their own trust in healthcare, or that their trust would increase. This number is an increase compared to the 2007 survey, when just over half [51.9% (95% CI 48.0-55.2)] indicated that their own trust would either not be influenced, or would increase. CONCLUSIONS: The study reveals a shift towards a more accepting attitude concerning PAS among physicians in Sweden. Only a minority of the respondents stated that they were against PAS, and a considerable proportion reported being prepared to prescribe the needed drugs for patient self-administration if PAS were legalized.

Personal responsibility for health? A phenomenographic analysis of general practitioners' conceptions.

OBJECTIVE: To analyse and describe general practitioners' perceptions of the notion of a 'personal responsibility for health'. DESIGN: Interview study, phenomenographic analysis. SETTING: Swedish primary health care. SUBJECTS: General Practitioners (GPs). MAIN OUTCOME MEASURES: Using the phenomenographic method, the different views of the phenomenon (here: personal responsibility for health) were presented in an outcome space to illustrate the range of perceptions. RESULTS: The participants found the notion of personal responsibility for health relevant to their practice. There was a wide range of perceptions regarding the origins of this responsibility, which was seen as coming from within yourself; from your relationships to specific others; and/or from your relationship with the generalized other. Furthermore, the expressions of this responsibility were perceived as including owning your health problem; not offloading all responsibility onto the GP; taking active measures to keep and improve health; and/or accepting help in health. The GP was described as playing a key role in shaping and defining the patient's responsibility for his/her health. Some aspects of personal responsibility for health roused strong emotions in the participants, especially situations where the patient was seen as offloading all responsibility onto the GP. CONCLUSION: The notion of personal responsibility for health is relevant to GPs. However, it is open to a broad range of interpretations and modulated by the patient-physician interaction. This may make it unsuitable for usage in health care priority settings. More research is mandated to further investigate how physicians work with patient responsibility, and how this affects the patient-physician relationship and the physician's own well-being.Key PointsThe notion of personal responsibility for health has relevance for discussions about priority setting and person-centred care.This study, using a phenomenographic approach, investigated the views of Swedish GPs about the notion of personal responsibility for health.The participants found the notion relevant to their practice. They expressed a broad range of views of what a personal responsibility for health entails and how it arises. The GP was described as playing a key role in shaping and defining the patient's responsibilities for his/her health.The notion was emotionally charged to the participants, and when patients were seen as offloading all responsibility onto the GP this gave rise to frustration.

Who should be tested in a pandemic? Ethical considerations.

BACKGROUND: In the initial phase of the Covid-19 pandemic, difficult decisions had to be made on the allocation of testing resources. Similar situations can arise in future pandemics. Therefore, careful consideration of who should be tested is an important part of pandemic preparedness. We focus on four ethical aspects of that problem: how to prioritize scarce testing resources, the regulation of commercial direct-to-consumer test services, testing of unauthorized immigrants, and obligatory testing. MAIN TEXT: The distribution of scarce resources for testing: We emphasize the use of needs-based criteria, but also acknowledge the importance of choosing a testing strategy that contributes efficiently to stopping the overall spread of the disease. Commercial direct-to-consumer test services: Except in cases of acute scarcity, such services will in practice have to be allowed. We propose that they should be subject to regulation that ensures test quality and adequate information to users. Testing of unauthorized immigrants, their children and other people with unclear legal status: Like everyone else, these individuals may be in need of testing, and it is in society's interest to reach them with testing in order to stop the spread of the disease. A society that offers comprehensive medical services to unauthorized immigrants is in a much better position to reach them in a pandemic than a society that previously excluded them from healthcare. Obligatory testing: While there are often strong reasons for universal testing in residential areas or on workplaces, there are in most cases better ways to achieve testing coverage than to make testing mandatory. CONCLUSION: In summary, we propose (1) decision-making primarily based on needs-based criteria, (2) strict regulation but not prohibition of direct-to-consumer test services, (3) test services offered to unauthorized immigrants, preferably as part of comprehensive medical services, and (4) broad outreach of testing services whenever possible, but in general not obligatory testing.

Novel drug candidates targeting Alzheimer's disease: ethical challenges with identifying the relevant patient population.

Intensive research is carried out to develop a disease-modifying drug for Alzheimer's disease (AD). The development of drug candidates that reduce Aß or tau in the brain seems particularly promising. However, these drugs target people at risk for AD, who must be identified before they have any, or only moderate, symptoms associated with the disease. There are different strategies that may be used to identify these individuals (eg, population screening, cascade screening, etc). Each of these strategies raises different ethical challenges. In this paper, we analyse these challenges in relation to the risk stratification for AD necessary for using these drugs. We conclude that the new drugs must generate large health benefits for people at risk of developing AD to justify the ethical costs associated with current risk stratification methods, benefits much larger than current drug candidates have. This conclusion raises a new set of ethical questions that should be further discussed.

Should we accept a higher cost per health improvement for orphan drugs? A review and analysis of egalitarian arguments.

In recent years, the issue of accepting a higher cost per health improvement for orphan drugs has been the subject of discussion in health care policy agencies and the academic literature. This article aims to provide an analysis of broadly egalitarian arguments for and against accepting higher costs per health improvement. More specifically, we aim to investigate which arguments one should agree upon putting aside and where further explorations are needed. We identify three kinds of arguments in the literature: considerations of substantial equality, formal equality, and opportunity cost. We argue that considerations of substantial equality do not support higher costs per health improvement orphan drugs, even if such considerations are considered valid. On the contrary, arguments of formal equality may support accepting a higher cost per health improvement for orphan drugs. However, in order to do so, a number of both normative and empirical issues must be resolved; these issues are identified in the article. For instance, it must be settled to what extent the opportunity cost in terms of foregone health for other patients is acceptable in order to uphold formal equality. We conclude that certain arguments can be set aside, and future focus should be put on the unresolved normative and empirical issues related to formal equality and opportunity cost.

Genetic testing for breast cancer risk, from BRCA1/2 to a seven gene panel: an ethical analysis.

BACKGROUND: Genetic testing is moving from targeted investigations of monogenetic diseases to broader testing that may provide more information. For example, recent health economic studies of genetic testing for an increased risk of breast cancer suggest that it is associated with higher cost-effectiveness to screen for pathogenic variants in a seven gene panel rather than the usual two gene test for variants in BRCA1 and BRCA2. However, irrespective of the extent to which the screening of the panel is cost-effective, there may be ethical reasons to not screen for pathogenic variants in a panel, or to revise the way in which testing and disclosing of results are carried out. MAIN TEXT: In this paper we discuss the ethical aspects of genetic testing for an increased risk of breast cancer with a special focus on the ethical differences between screening for pathogenic variants in BRCA1/2 and a seven gene panel. The paper identifies that the panel increases the number of secondary findings as well as the number of variants of uncertain significance as two specific issues that call for ethical reflection. CONCLUSIONS: We conclude that while the problem of handling secondary findings should not be overstated with regard to the panel, the fact that the panel also generate more variants of uncertain significance, give rise to a more complex set of problems that relate to the value of health as well as the value of autonomy. Therefore, it is insufficient to claim that the seven gene panel is preferable by only referring to the higher cost effectiveness of the panel.

Against Ulysses contracts for patients with borderline personality disorder.

Patients with borderline personality disorder (BPD) sometimes request to be admitted to hospital under compulsory care, often under the argument that they cannot trust their suicidal impulses if treated voluntarily. Thus, compulsory care is practised as a form of Ulysses contract in such situations. In this normative study we scrutinize the arguments commonly used in favour of such Ulysses contracts: (1) the patient lacking free will, (2) Ulysses contracts as self-paternalism, (3) the patient lacking decision competence, (4) Ulysses contracts as a defence of the authentic self, and (5) Ulysses contracts as a practical solution in emergency situations. In our study, we have accepted consequentialist considerations as well as considerations of autonomy. We conclude that compulsory care is not justified when there is a significant uncertainty of beneficial effects or uncertainty regarding the patient's decision-making capacity. We have argued that such uncertainty is present regarding BPD patients. Hence, Ulysses contracts including compulsory care should not be used for this group of patients.