Loss Of Decision-making Capacity Research Articles

The ethical inadequacy of uninformed surrogate consent: advancing respect for persons in clinical research.

In clinical research, decision-making capacity is often equated with unspecified conceptions of autonomy, and autonomy is often equated with personhood. On this view, the loss of decision-making capacity is seen as a loss of autonomy, and the loss of autonomy subsumes a loss of personhood. An ethical concern arises at the intersection of those philosophical considerations with the legal considerations in informed consent. Because persons with inadequate decision-making capacity cannot provide legally effective consent, enrollment in research can occur only if a surrogate gives permission on the person's behalf. Federal regulations and resulting institutional policies allow permission from surrogates empowered under state law to consent to medical treatment procedures, typically in a hierarchy of legislatively prioritized relationships lacking regard for what the surrogate actually knows about the current research-related values and preferences of the potential subject. As a result, the research enterprise often countenances reliance on surrogates who have no relational or informational basis for an enrollment decision that aligns with the values and preferences of the subject. Arguing from the perspective that losing decision-making capacity does not alter the moral status of persons, and that respect for persons rather than respect for autonomy is the central ethical obligation, I assess the ethical implications of allowing persons with no knowledge of the values and preferences of the potential subject to make enrollment decisions, concluding that reliance on uninformed surrogates is not an ethically defensible approach to enrolling subjects in clinical research.

End-of-life practices in Hong Kong intensive care units: results from the Ethicus-2 study.

The need for end-of-life care is common in intensive care units (ICUs). Although guidelines exist, little is known about actual end-of-life care practices in Hong Kong ICUs. The study aim was to provide a detailed description of these practices. This prospective, multicentre observational sub-analysis of the Ethicus-2 study explored end-of-life practices in eight participating Hong Kong ICUs. Consecutive adult ICU patients admitted during a 6-month period with life-sustaining treatment (LST) limitation or death were included. Follow-up continued until death or 2 months from the initial decision to limit LST. Of 4922 screened patients, 548 (11.1%) had LST limitation (withholding or withdrawal) or died (failed cardiopulmonary resuscitation/brain death). Life-sustaining treatment limitation occurred in 455 (83.0%) patients: 353 (77.6%) had decisions to withhold LST and 102 (22.4%) had decisions to withdraw LST. Of those who died without LST limitation, 80 (86.0%) had failed cardiopulmonary resuscitation and 13 (14.0%) were declared brain dead. Discussions of LST limitation were initiated by ICU physicians in most (86.2%) cases. Shared decision-making between ICU physicians and families was the predominant model; only 6.0% of patients retained decision-making capacity. Primary medical reasons for LST limitation were unresponsiveness to maximal therapy (49.2%) and multiorgan failure (17.1%). The most important consideration for decision-making was the patient's best interest (81.5%). Life-sustaining treatment limitations are common in Hong Kong ICUs; shared decision-making between physicians and families in the patient's best interest is the predominant model. Loss of decision-making capacity is common at the end of life. Patients should be encouraged to communicate end-of-life treatment preferences to family members/surrogates, or through advance directives.

Experiences of healthcare providers with eligible patients' loss of decision-making capacity while awaiting medical assistance in dying.

Background:In Canada, under Bill C-14, patients who met all eligibility requirements were prevented from accessing medical assistance in dying (MAiD) following their loss of decision-making capacity while awaiting MAiD. The changes introduced with Bill C-7 continue to limit access to patients who did not enter a waiver of final consent agreement with their healthcare providers. Little is known about the experiences with patients’ loss of capacity to consent and subsequent ineligibility for MAiD. Understanding healthcare providers’ experiences has important implications for improving end-of-life care for those with capacity-limiting conditions.Purpose:To explore Canadian healthcare providers’ experiences with end-of-life of eligible patients who became ineligible for MAiD due to their loss of decision-making capacity to consent and the relational influences on their experiences prior to the implementation of Bill C-7 in Canada.Method:A critical qualitative methodology and a feminist ethics theoretical lens guided this study. A voice-centred relational approach that allowed an in-depth exploration of how power, relationality and moral agency influenced participants’ experiences was used for data analysis. Data consisted of semi-structured interviews with 30 healthcare providers.Findings:The analysis resulted in the following four main themes and corresponding subthemes: (1) identifying factors that may result in ineligibility for MAiD due to capacity loss; (2) maintaining eligibility required to access MAiD; (3) preparing for an alternative end-of-life; (4) experiencing patients’ capacity loss.Discussion:This study highlights that while MAiD is legally available to eligible Canadians, access to MAiD and care for eligible patients who were unable to access MAiD due to their loss of decision-making varied based on the geographical locations and access to willing MAiD and end-of-life care providers. The availability of high-quality palliative care for patients throughout the MAiD process, including following the loss of capacity to consent and subsequent ineligibility, would improve the end-of-life experience for all those involved. The need to establish a systematic approach to prepare and care for patients and their families following the patients’ loss of capacity and subsequent ineligibility for MAiD is also identified.

Advance Care Planning and Shared Decision-Making: Paving the Way

"Advance care planning (ACP) has become widely used in medical care in order to plan ahead of a loss of decision-making capacity. Since ACP aim is to promote anticipatory and substitute autonomy by engaging people ‒ and possibly their relatives ‒ in deciding about future goals of care and treatments, scientific literature in this field often posits that ACP involve shared decision-making. This assumption however is rarely backed up by an in-depth reflection on how shared decision-making might operate within ACP and which shared decision-making template is more likely to foster ACP. Our ACP tool, based on a model created at the Zurich University Hospital (Krones et al, 2019), engages patients in a structured communicational process about their values and preferences for care. In this tool, ACP facilitators help patients set goals of care and document treatments decisions in three paradigmatic situations of loss of decision-making capacity. Because our ACP tool entails discussions about goals of care, quality of life, and options in terms of disease- or symptom-management, we turned to Elwyn and al.’s three talk’s model (2012) and Vermunt et al.’s three level goal model (2018) in order to incorporate elements of shared decision-making in our ACP tool. In this presentation we discuss how these models might be combined in order to foster shared decision-making within our ACP tool and, by then, broaden its scope and eventually improve its effectiveness, strengthen its theoretical foundations and uphold the ethics of care in the event of a loss of decision-making capacity. "

Advance decisions, welfare attorneys and statements of wishes: The belt, braces and corset approach to advance care planning

Advance care planning is used by adults to express value-based preferences for informing future care and treatment decisions following their loss of decision-making capacity. It is a means for ascertaining previous preferences about types of care and treatment as well as wider concerns. In English law, advance care planning incorporates advance decisions to refuse treatment, statements of wishes and, more recently, the appointment of attorneys who act under the authority of a Lasting Power of Attorney for health and welfare. This article considers these mechanisms together with some of their merits and potential shortcomings. It also considers whether other approaches, such as advance consent, might be a useful addition. Ultimately, it argues that used in isolation the current options are insufficient on legal and pragmatic grounds, albeit for different reasons. For persons with a strong sense of their personal treatment and care preferences following their loss of decision-making capacity, a combined and synergistic approach is recommended.

THE LEAD GUIDE: LIFE PLANNING IN EARLY ALZHEIMER’S AND DEMENTIA

To address the characteristics of Alzheimer’s disease and related dementias (ADRD) that complicate end-of-life (EOL), we created and validated a dementia-specific EOL planning instrument. This instrument can be used to facilitate discussions and provide documentation of EOL values and care preferences prior to loss of decisional capacity. Instrument development used a mixed-method design that included: a) conducting a series of focus groups (healthy adults, persons with early-stage ADRD, and dementia caregivers) to develop and confirm content, comprehensiveness, and usability, b) evaluation by content experts to verify instrument utility in clinical practice; and c) conducting a national survey of healthy older adults and adults with early-stage ADRD to evaluate instrument psychometric properties. We describe the expansion of the instrument from survey tool into a user-friendly guide: “The LEAD Guide” or Life-Planning in Early Alzheimer’s and Dementias Guide. We describe the utility of the LEAD Guide for persons planning ahead for the possibility of ADRD, those with MCI and their families, for providers to use with patients and families, and for researchers studying the EOL preferences and values of persons in these populations. Instructions specific to each user group are health literacy appropriate, and include a glossary of terms. Age-friendly graphic design and availability in both print and e-versions enhance utility. The LEAD Guide can be utilized to help inform EOL care decisions and ensure that they align with the patient’s values and may serve as the basis of an intervention to support choice in persons with dementia.

Perceptions of hospitalized patients and their surrogate decision makers on dialysis initiation: a pilot study

BackgroundDialysis is often initiated in the hospital during episodes of acute kidney injury and critical illness. Little is known about how patients or their surrogate decision makers feel about dialysis initiation in the inpatient setting.MethodsWe conducted a prospective cohort study at a large academic center in the United States. All patients who initiated dialysis during a 30-day period in 2016 were approached for enrollment. Study participants were defined as individuals who provided consent for dialysis initiation – either the patient or a surrogate decision-maker. Decisional satisfaction and the degree of shared decision-making were assessed using the decisional attitude scale and the control preferences scale, respectively. These scales were incorporated into a study questionnaire along with an exploratory structured interview.ResultsA total of 31 potential participants were eligible and 21 agreed to participate in the study. Continuous renal replacement therapy was used in 14 out of 21 cases (67%) and there was 33% in-hospital mortality in the study cohort. A majority (62%) of patients were unable to participate in the consent process for dialysis initiation and had to rely on a surrogate decision-maker. The mean score for the decisional attitude scale was 4.1 (95% CI 3.8–4.3) with a score of 5 corresponding to high decisional satisfaction. Most of the decisions were classified as shared and incorporated input from clinicians as well as patients or surrogates. Although 90% of participants agreed that they had a choice in making the decision, 81% were unable to mention any alternatives to dialysis initiation.ConclusionsDialysis initiation was associated with high decisional satisfaction and most participants felt that the decision incorporated input from patients and providers. However, inpatient dialysis initiation was commonly associated with loss of decisional capacity and reliance on a surrogate decision-maker. This finding is likely driven by critical illness. Survivors of critical illness who remain dialysis dependent may need to revisit conversations about the rationale, risks, and benefits of dialysis.

End-of-Life Care Planning for Lesbian, Gay, Bisexual, and Transgender Individuals

Advance care planning is important for all adults. To facilitate conversations about patients' preferences, clinicians need to be aware of how identities and relationships may shape priorities and concerns. This qualitative study solicited advance care planning priorities among lesbian, gay, bisexual, and transgender (LGBT) individuals to explore whether sexual orientation and gender identity shape concerns about care at the end of life. Data were collected from 30 LGBT adults on the east coast through focus groups and interviews using purposive sampling. Transcribed discussions were analyzed using grounded theory. Participants regarded end of life as any period after the loss of decision-making capacity and felt strongly that individuals in that state would need an advocate to ensure that they were cared for with respect and dignity; many lacked confidence that the health care system would do so without prompting. Participants who had partners or children hoped that family would serve as advocates but worried that they might outlive their partners; participants who were single worried that the advocate role was too great a burden to ask of friends or distant relatives. Providers can encourage open dialogue and more fully capture LGBT patients' needs through sensitive, respectful communication and by creating environmental signals of LGBT inclusivity.

The impact of the Eastern enlargement on the decision-making capacity of the European Union

ABSTRACTThis contribution investigates the impact of the Eastern enlargement on the decision-making capacity of the European Union. On the basis of new data on the number and types of legal acts produced by the EU (1994–2014) and on the time between the proposal and adoption of legislative acts (1994–2012), the contribution argues that enlargement has had a rather limited impact on legislative production and duration and that it is extremely hard to disentangle this impact from other contemporaneous institutional and socioeconomic developments. On the basis of analyses of expert-based policy positions of member states in EU negotiations and on voting data from the Council of Ministers of the EU, it is argued that enlargement has possibly added a new dimension of contestation in EU legislative decision-making, but one that concerns a relatively small share of all negotiations in few policy fields like environment. All in all, there is no evidence that the Eastern enlargement has led to the institutional gridlock and loss of decision-making capacity that the public, many politicians and some academics as well have feared.

Evaluation of Informed Consent for Withholding and Withdrawal of Life Support in Korean Intensive Care Units

Background: The goal of this study was to analyze the process and characteristics of withholding or withdrawal of life support (WLS) in Korean intensive care units (ICUs). Methods: This was a single-centered retrospective analysis of patients who died in the ICUs of a tertiary hospital in Korea from January to December 2012. WLS informed consents and clinical data were analyzed. Results: Of 285 deaths during the study period, informed consents for WLS were obtained from 228 patients (80.0%). All WLS decisions were made by family members after the patient’s loss of decision-making capacity. Decisions were made most frequently by the patient’s son (50.6%). Patients in the WLS group were older than those in the non-WLS group, and older age was associated with the WLS decision. Thirty-seven patients (16.2%) died within one hour of WLS approval, and 182 patients (79.8%) died on the day of WLS approval. The most frequently withheld life support modality was chest compression (100%), followed by defibrillation (95.9%) and pacemaker insertion (63.3%). Conclusions: Aggressive and invasive life support measures were those most frequently withheld or withdrawn by decision-makers in Korean ICUs. The most common proxy was the son, rather than the spouse.

There's Nothing New in Dying Now: Will Welfare Attorney Decision Making at End of Life Make a Real Difference?

Advance care planning is a way to express value‐based preferences in order to guide future treatment decisions following loss of decision‐making capacity. It aims to ensure that one's critical values continue to influence healthcare decisions, particularly at end of life. The Mental Capacity Act 2005 permits adults with capacity to appoint welfare attorneys to act as their proxy decision‐makers following loss of capacity. A focus group study was used to explore the views and perceptions of lawyers and health professionals to attorney decision making at end of life. Whilst participants gave a guarded welcome to the introduction of healthcare and welfare attorneys, potential challenges were identified, based upon professional norms and expectations. A shared consensus was that the realization of the full potential of proxy decision making was likely to be a theoretical, rather than real, benefit. Opinions were divided on elemental tenets such as prospective autonomy, best interests, and the potential for conflict.

When the profession becomes personal: dementia care practitioners as family caregivers

Little is known about the impact of caring experience on the practice of dementia care professionals. Few research studies covering dementia practice ask about personal experiences of providing care or having a family member with dementia. In England and Wales, the Mental Capacity Act (MCA) 2005 provided a new legal framework for planning and decision-making in the event of possible loss of capacity. Professional activities in this area include advice and assistance with arranging proxy decision-making, establishing wishes, and advance decisions. The aim of this paper is to present interview data from dementia care professionals with family experiences of dementia and their reflections on decision-making frameworks. A total of 123 dementia care professionals working in community and care home settings were interviewed (2007-2010) about their experiences and expectations of the MCA 2005. Additional questions covered experiences of being family members or carers of a person with dementia and any use of the planning and decision-making provisions of the MCA in personal and family contexts. Data were analyzed thematically. Seventy practitioners had experience of family members with dementia and family caring. Decision-making and planning were viewed as easier under the MCA but tensions could arise around loss of decision-making capacity or family dispute. Empathy for caregiving situations and how things could have been different were reflected upon. Trainers, clinical supervisors, and researchers in dementia care may build upon personal experience of some practitioners to promote empathy with other family carers and the provision of timely information and advice.

‘More of a leg to stand on’: Views and usage of the Mental Capacity Act 2005 among staff of local Alzheimer's Society and carer organisations

Objectives: The Mental Capacity Act (MCA) 2005 was implemented in 2007 in England and Wales. It offers new opportunities for people to plan for any future loss of capacity and provides a framework for decision-making on behalf of people lacking capacity. This article explores the challenges staff in local voluntary organisations focusing on dementia and carers face when they offer information and advice connected to possible loss of decision-making capacity to people with dementia and carers. Method: A set of 17 qualitative interviews were undertaken with a purposively sampled voluntary sector staff in London in 2008–09. Framework analysis was used to delineate themes in the transcripts and identified themes were included in the iteratively developed coding framework Results: Interviews revealed that voluntary sector staff generally perceived the Act as largely benefiting people with dementia in the exercise of their rights. They also thought that carers would benefit from the Act's provisions, whilst their own involvement in advice, information-giving and referral to other sources of expertise in relation to the MCA differed according to their role and confidence. Voluntary sector staff's capability and interest in using the MCA vary; there should be no presumption of detailed knowledge, and resources relevant to the MCA might be need to be coordinated more effectively by this sector. Conclusion: Ongoing training, local coordination and auditing seem warranted. These could encompass the new safeguarding provisions of the MCA which may need to be highlighted as part of the welcome extension of rights conferred by the MCA.

Clinical trials in status epilepticus—The clinical perspective

Considering that status epilepticus (SE) is relatively frequent in neurologic practice, it is surprising that there are only a few randomized controlled studies (RCTs) on drug interventions reported (Prasad et al., 2005). For SE, observational studies seem to be easier to undertake, as carrying out RCTs in the emergency situation is problematic. The need for medical research programs involving patients with SE is real and profound. Only in wellperformed clinical trials can hypotheses of clinical efficacy and safety be tested. However, involving this patient category in interventional trials raises ethical, juridical, and practical concerns. Clinical trials in patients with SE in emergency and critical care settings frequently involve patients with loss of decision-making capacity and, given the emergency nature of SE, facing very short therapeutic time frames. In planning a trial it is essential to define clearly the SE phenotype to be studied. The response to treatment is greatly influenced by the duration of the SE before enrollment, response to previous therapy, SE type, etiology, and comorbidities. There is a relationship between ethnicity, socioeconomic status, and the incidence of SE. Outcome is influenced by the age of the patient. Therefore, studies should ideally be stratified to deal with these potential confounders (Neville et al., 2007). However, this means large sample sizes. On the other hand, accurate data about these prognostic factors are not always available at the time of enrollment, and excessively restrictive inclusion criteria or too broad exclusion criteria may limit the enrollment too extensively. Informed consent in SE research can-given the emergency nature and severity of the condition, or due to pharmacologic sedation-seldom be obtained from patients themselves. Delaying the treatment to obtain informed patient or proxy consent might jeopardize both the life of the patient and the results of the trial. Several solutions are in use for obtaining consent in emergency situations. Proxies (legal representatives) or an independent physician can give consent before inclusion in research, or (patient or proxy) consent can be deferred for some time, or consent can even be waived (Jansen et al., 2009). The problems in getting the consent from a proxy include that proxies are not always available in the first moments of hospital or intensive care admission, or they are too overwhelmed to understand the provided information to give valid consent. Because of the problems in obtaining consent, patients included are often not representative of the typical SE population, and results of the trials, therefore, have low external validity. It is no longer possible to treat SE with placebo. Therefore, although the RCT is always considered to be the gold standard, there are many limitations in the context of SE trials. Active comparator trials are possible, but true blinding is often also difficult or sometimes impossible. In addition, the most important question is not related to drug efficacy, but rather to strategies for the management of SE and generating guidelines that can be widely incorporated into clinical practice. Good outcome after SE usually means cessation of seizures within a certain time period after the drug administration, absence of seizure recurrence within the next 24 h, and return to baseline neurologic function. The control of seizures can mean only clinical control or both clinical and electrographic control of SE. Secondary outcome measures include clinical outcome with a functional scale, incidence of focal neurologic deficits, incidence of epilepsy, incidence of cognitive decline, response by initial electroencephalography (EEG) findings, 30-day mortality, need for intensive care unit (ICU) treatment, time of ventilator treatment in patients treated in the ICU, incidence of thromboembolism, incidence of infectious complications requiring specific treatment, incidence of hypotension requiring specific treatment, and incidence of propofol infusion syndrome or other specific complications/adverse effects. It is also extremely important to follow carefully the vital signs and electrocardiography (ECG) as well as laboratory values when testing a new molecule. There are several areas requiring attention in future research in SE. A universally acceptable definition of Address correspondence to Reetta K lvi inen, MD, PhD, Neurologist, Director, Kuopio Epilepsy Center, Kuopio University Hospital, PO Box 1777, 70211 Kuopio, Finland. E-mail: reetta.kalviainen@kuh.fi

Two steps forward, one step back: advance care planning, Australian regulatory frameworks and the Australian Medical Association

The Australian Medical Association has recently adopted a policy position concerning advance care planning, which is generally supportive of extending patient self-determination beyond the loss of decision-making capacity. It calls for uniform national legislation for legally enforceable advance health directives (AHD), and statutory protection for practitioners who comply with valid AHD, or who do not comply on several grounds. Analysis of the grounds for non-compliance indicate that they undermine patient autonomy, and aspects of the policy are inconsistent with current common law and statutory regimes that allow an adult to complete a legally binding AHD. The policy therefore threatens the patient self-determination, which it endorses, and places doctors who participate in advance care planning at legal risk.

Personhood, patienthood, and clinical practice: Reassessing advance directives.

This article considers 2 major critiques of advance directives and offers a defense to each of them. The 1st critique is philosophical in nature and maintains that the moral authority of an advance directive is undercut by a failure of personal identity to survive the loss of decisional capacity. The response in this article is that this critique relies on a flawed and disfavored concept of persons and their persistence over time. The 2nd critique, pragmatic in nature, argues that advance directives cannot be authoritative because the requisite elements of an informed consent to or refusal of treatment are rarely present, and many such instruments are ambiguous. The author argues that if the creation of advance directives, as a form of advance care planning, is made an integral aspect of clinical practice, many more patients will elect to execute directives, and those directives will not be ambiguous.