A pragmatist's guide to the assessment of decision-making capacity.

Choice, understanding, appreciation and reasoning compose the standard model of decision-making capacity. Difficulties in determining capacity can arise when patients exhibit partial impairment. We suggest that a pragmatic approach, focusing on how capacity status affects the ultimate decision to override the patient's wishes, can help evaluators resolve difficult cases.Declaration of interestNone.

Structured assessment of mental capacity to make financial decisions in Chinese older persons with mild cognitive impairment and mild Alzheimer disease.

Previous studies suggested that patients with mild cognitive impairment (MCI) or dementia can have impaired and declining financial skills and abilities. The purpose of this study is to test a clinically applicable method, based on the contemporary legal standard, to examine directly the mental capacity to make financial decisions and its component decision-making abilities among patients with MCI and early dementia. A total of 90 patients with mild Alzheimer disease (AD), 92 participants with MCI, and 93 cognitively normal control participants were recruited for this study. Their mental capacity to make everyday financial decisions was assessed by clinician ratings and the Chinese version of the Assessment of Capacity for Everyday Decision-Making (ACED). Based on the clinician ratings, only 53.5% were found to be mentally competent in the AD group, compared with 94.6% in the MCI group. However, participants with MCI had mild but significant impairment in understanding, appreciating, and reasoning abilities as measured by the ACED. The ACED provided a reliable and clinically applicable structured framework for assessment of mental capacity to make financial decisions.

Neuropsychological correlates of capacity determinations in Alzheimer disease: implications for assessment.

OBJECTIVES: To explore the neuropsychological correlates of the capacity to consent to research and to appoint a research proxy among persons with Alzheimer disease. DESIGN, SETTING, AND PARTICIPANTS: Interview study of 77 persons with Alzheimer disease recruited through an Alzheimer disease research center and a memory disorder clinic. MEASUREMENTS: The capacity to consent to two research scenarios (a drug randomized clinical trial and a neurosurgical clinical trial) and the capacity to appoint a research proxy were determined by five experienced consultation psychiatrists who rendered categorical judgments based on videotaped interviews of the MacArthur Competence Assessment Tool-Clinical Research and the Capacity to Appoint a Proxy Assessment. Mattis Dementia Rating Scale-Second Edition was used to assess neuropsychological functioning. RESULTS: The capacity to appoint a proxy and to consent to the drug randomized clinical trial, as determined by a majority or greater opinion of the five-psychiatrist panel, was predicted by Conceptualization and Initiation/Perseveration subscales, whereas the capacity to consent to a neurosurgical randomized clinical trial was predicted by the Memory subscale. Furthermore, the more lenient individual psychiatrists' judgments were predicted by the Conceptualization subscale, whereas the stricter psychiatrists' judgments were predicted by the Memory subscale. CONCLUSIONS: How experienced psychiatrists view the capacity of patients with Alzheimer disease for consenting to research and for appointing a proxy may be related to the patients' conceptualization and memory functioning. More explicit and standardized guidance on the role of short-term memory in capacity determinations may be useful.

Advancing Alzheimer's disease diagnosis, treatment, and care: recommendations from the Ware Invitational Summit.

To address the pending public health crisis due to Alzheimer's disease (AD) and related neurodegenerative disorders, the Marian S. Ware Alzheimer Program at the University of Pennsylvania held a meeting entitled "State of the Science Conference on the Advancement of Alzheimer's Diagnosis, Treatment and Care," on June 21-22, 2012. The meeting comprised four workgroups focusing on Biomarkers; Clinical Care and Health Services Research; Drug Development; and Health Economics, Policy, and Ethics. The workgroups shared, discussed, and compiled an integrated set of priorities, recommendations, and action plans, which are presented in this article.

How should we use age to ration health care? Lessons from the case of kidney transplantation.

Competing visions for health reform in the United States and renewed interest in health technology assessment (HTA) have led to fierce national debates about the appropriateness of rationing. Because of a limited supply of organs, kidney transplantation has always required rationing and overt discussion of the ethics that guide it, but the field of transplantation has also contended recently with internal calls for a new rationing system. The aim of the Life Years from Transplantation (LYFT) proposal is to allocate kidneys to patients who obtain the greatest survival benefit from transplantation, which would lengthen the lives of kidney transplant recipients but restrict the ability of older Americans to obtain a transplant. The debate around the LYFT proposal reveals the ethical and policy challenges of identifying which patients should receive a treatment based on the results of cost-effectiveness and other HTA studies. This article argues that attempts to use HTA for healthcare rationing are likely to disadvantage older patients. Guiding principles to help ensure that resources such as kidneys are justly allocated across the life span are proposed.

Design of comprehensive Alzheimer's disease centers to address unmet national needs.

The problem of Alzheimer's disease (AD) exemplifies the challenges of dealing with a broad range of aging-related chronic disorders that require long-term, labor-intensive, and expensive care. As the baby boom generation ages and brain diseases become more prevalent, the need to confront the pending health care crisis is more urgent than ever before. Indeed, there is now a critical need to expand significantly the national effort to solve the problem of AD, with special focus on prevention. The Campaign to Prevent Alzheimer's Disease by 2020 (PAD2020) aims to create a new paradigm for planning and supporting the organization of worldwide cooperative research networks to develop new technologies for early detection and treatments of aging-related memory and motor impairments. PAD 2020 is developing an implementation plan to justify (1) increasing the federal budget for research, (2) developing novel national resources to discover new interventions for memory and motor disorders, and (3) creating innovative and streamlined decision-making processes for selecting and supporting new ideas. Since 1978 the National Institute on Aging or National Institute of Health (NIH) established an extensive national network of AD research facilities at academic institutions including AD Centers (ADCs), Consortium to Establish a Registry for AD, AD Cooperative Study (ADCS), AD Drug Discovery Program, National Alzheimer's Coordinating Center, National Cell Repository for AD, and AD Neuroimaging Initiative. However, despite the success of these programs and their critical contributions, they are no longer adequate to meet the challenges presented by AD. PAD 2020 is designed to address these changes by improving the efficiency and effectiveness of these programs. For example, the ADCs (P30s and P50s) can be enhanced by converting some into Comprehensive Alzheimer's Disease Centers (CADCs) to support not only research, but also by being demonstration projects on care/treatment, clinical trials, and education as well as by seamlessly integrating multisite collaborative studies (ADCS, AD Neuroimaging Initiative, Patient Registries, Clinical Data Banks, etc) into a cohesive structure that further enhances the original mission of the National Institute on Aging ADCs. Regional CADCs offer greater efficiency and cost savings while serving as coordinating hubs of existing ADCs, thereby offering greater economies of scale and programmatic integration. The CADCs also broaden the scope of ADC activities to include research on interventions, diagnosis, imaging, prevention trials, and other longitudinal studies that require long-term support. Thus, CADCs can address the urgent need to identify subjects at high risk of AD for prevention trials and very early in the course of AD for clinical trials of disease modification. The enhanced CADCs will allow more flexibility among ADCs by supporting collaborative linkages with other institutions and drawing on a wider expertise from different locations. This perspective article describes the University of Pennsylvania (Penn) CADC Model as an illustrative example of how an existing ADC can be converted into a CADC by better utilization of Penn academic resources to address the wide range of problems concerning AD. The intent of this position paper is to stimulate thinking and foster the development of other or alternative models for a systematic approach to the study of dementia and movement disorders.

Preference-based quality of life in patients with Alzheimer's disease.

BACKGROUND: This study was developed to evaluate the feasibility, reliability, and validity of use of patients' ratings of health preference measures as outcomes for cost-effectiveness analyses in persons with very mild to moderate Alzheimer's disease (AD). METHODS: Patients and caregivers completed ratings of the EuroQol-5D system (EQ-5D) and the Health Utilities Index Mark 2 (HUI2) and instruments that assess cognition, mood, insight, AD-specific and generic health-related quality of life (QOL) and activities of daily living. RESULTS: Patients' HUI2 scores were reliable. EQ-5D scores were somewhat less so. Patients rated their utility high, with overall EQ-5D and HUI2 scores greater than 0.8. Neither the EQ-5D nor the HUI2 scores had a relationship with severity of cognitive impairment. Both the EQ-5D and the HUI2 had expected relationships with patient-rated measures of QOL, function, mood, and specific subscales we hypothesized should be associated with patient preferences. Patient insight into functional and cognitive impairments had little association with their health preference scores. CONCLUSIONS: AD patients' scores on the EQ-5D and the HUI2 have many of the characteristics of valid preference measures. However, the proportions of persons who do not perceive any disability, the lack of association with the caregivers' ratings of activities of daily living, limited associations with insight, and no association with their Mini-Mental State Exam scores suggest that patients' reports of disability might reflect legitimate self-perceptions of mood and function that are associated with comorbidities rather than with AD.

Caregivers' assessments of preference-based quality of life in Alzheimer's disease.

BACKGROUND: This study was designed to evaluate the feasibility, reliability, and validity of use of caregivers' ratings of two health preference measures as outcomes for cost-effectiveness analyses in persons with very mild to moderate Alzheimer's disease (AD). METHODS: Caregivers completed ratings of preference for AD patients' health by use of the EuroQol-5D system (EQ-5D) and the Health Utilities Index Mark 2 (HUI2). They also rated patients' cognition, mood, burden, AD-specific and generic health-related quality of life (QOL), and activities of daily living. RESULTS: Caregivers' HUI2 scores were reliable. Neither the caregiver ratings of the patients' health by use of the EQ-5D nor the HUI2 had a relationship with severity of cognitive impairment. Both the EQ-5D and the HUI2 had expected relationships with caregivers' assessments of patients' function, AD-specific QOL, and physical and mental health and selected subscales of the measures of AD-specific QOL and overall health. In addition, caregiver scores showed relationships with patient self-rated function, mood, and physical health but not AD-specific QOL. Caregiver burden was associated with caregivers' scores. CONCLUSIONS: Caregiver-completed ratings of preference for patients' health made by use of the EQ-5D and the HUI2 have many of the characteristics of valid preference measures. However, the lack of association with patient Mini-Mental Status Exam scores and patient self-rated AD-specific QOL and the associations with caregiver subjective burden might present limitations to their use as proxy measures for cost-effectiveness analyses.

Identifying the barriers and challenges to voting by residents in nursing homes and assisted living settings.

To ascertain the need for and to inform development of guidelines for voting in long-term care settings, we conducted a telephone survey of Philadelphia nursing (n = 31) and assisted living (n = 20) settings following the 2003 election. Substantial variability existed in procedures used for registration and voting, in staff attitudes, and in the estimated proportion of residents who voted (29%+/-28, range 0-100%). Residents who wanted to vote were unable to do so at nearly one-third of sites, largely due to procedural problems. Nearly two-thirds of facilities indicated they assessed residents' voting capacity before the election. However, methods differed and may have disenfranchised residents who were actually competent to vote. Current procedures in many facilities fail to protect voting rights. These data suggest that rights might be better protected if election officials took charge of registration, filing absentee ballot requests, ballot completion, and trained LTC facility staff on voters' rights and reasonable accommodations.

Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: a cross-sectional study.

BACKGROUND: The ethics and science of using placebo control groups in clinical trials have been widely debated. Few studies, however, have examined factors associated with choice of control group. OBJECTIVE: Our aim was to assess the prevalence of use of placebo controls in randomized controlled trials in psoriasis and to identify factors associated with use of placebo controls in these trials. METHODS: This is a cross-sectional study of randomized controlled trials in psoriasis published from January 1, 2001 to December 20, 2005 and indexed in the Cochrane Central Register of Controlled Trials. We extracted data on types of control groups used, design issues (number of patients enrolled, primary end point), disease characteristics (psoriasis type and severity), and extrascientific issues (trial location, funding source, and year of publication). We used bivariable and multivariable logistic regression to determine factors associated with use of a placebo control group. RESULTS: Of 194 citations, 187 were available for review. One hundred thirty-five trials from 134 articles in 38 journals met inclusion criteria. Eighty-three trials (61.5%) enrolling 8171 subjects (41.7%) used active controls only, and 52 trials (38.5%) enrolling 11,406 subjects (58.3%) used placebo controls. Adjusted for trial location and funding source, trials significantly more likely to have used placebo controls included those conducted in the United States (odds ratio [OR], 5.79; 95% confidence interval [CI], 2.45-13.68; P < .001) and those funded by pharmaceutical companies (OR, 2.61; 95% CI, 1.19-5.73; P = .02). Predicted frequencies of placebo use ranged from 77.6% (industry-funded, conducted trials in the United States) to 18.6% (non-industry-funded trials not conducted in the United States). LIMITATIONS: Our searches may not have identified all published trials, and we did not have access to data from unpublished trials. CONCLUSIONS: Use of placebo controls has been more common in psoriasis trials conducted in the United States and funded by pharmaceutical companies. The findings suggest that ethical and scientific issues related to choice of control group in psoriasis trials are interpreted markedly differently depending on trial location and funding source.

Would caregivers of Alzheimer disease patients involve their relative in a decision to use an AD-slowing medication?

OBJECTIVES: The authors examined the factors associated with 1) caregivers' willingness to involve a relative with Alzheimer disease (AD) in a decision to use an AD-slowing treatment; and 2) how caregivers would resolve a disagreement over this decision with the their relative. METHODS: This was a cross-sectional interview study of 102 caregivers of patients with mild-to-severe-stage AD, enrolled in a University Memory Disorders Clinic. RESULTS: Forty-four percent of caregivers (45/102) said that his or her relative would participate in a decision to use an AD-slowing treatment. Logistic regression showed that having less dementia severity, being a female caregiver, and a spousal relationship were all associated with caregivers' involving their relative in this decision. Among the caregivers who said they would involve their relative, the majority said they would resolve disagreements over whether to use the treatment in favor of what the patient wanted, versus what the family wanted for the patient. Male caregivers were less likely to resolve disagreements in favor of the patients' preferences. CONCLUSION: Although most caregivers of patients in mild-to-moderate stages would include these patients in an AD treatment decision, certain caregiver characteristics, such as gender and relationship, are associated with not involving patients in this decision. Physicians working with dementia patients and their family members should take these characteristics into account when discussing treatment options and work with patient-caregiver dyads to improve the communication of preferences.

Addressing the ethical, legal, and social issues raised by voting by persons with dementia.

This article addresses an emerging policy problem in the United States participation in the electoral process by citizens with dementia. At present, health care professionals, family caregivers, and long-term care staff lack adequate guidance to decide whether individuals with dementia should be precluded from or assisted in casting a ballot. Voting by persons with dementia raises a series of important questions about the autonomy of individuals with dementia, the integrity of the electoral process, and the prevention of fraud. Three subsidiary issues warrant special attention: development of a method to assess capacity to vote; identification of appropriate kinds of assistance to enable persons with cognitive impairment to vote; and formulation of uniform and workable policies for voting in long-term care settings. In some instances, extrapolation from existing policies and research permits reasonable recommendations to guide policy and practice. However, in other instances, additional research is necessary.

Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials.

BACKGROUND: Paying patients to participate in clinical trials is ethically controversial. However, there has been no empirical documentation regarding whether payment represents an undue or unjust inducement. METHODS: To evaluate these questions, we described hypothetical placebo-controlled trials of a new antihypertensive drug to 126 patients with mild-to-moderate hypertension recruited from hypertension and general medicine clinics at a university hospital. Using a 3 x 3, within-subjects design, we altered a risk to participation (either adverse effect rate or rate of randomization to placebo) and the payment participants would receive ($100, $1000, and $2000) and asked patients to indicate their willingness to participate (WTP) in each trial using a 6-point scale. RESULTS: Clustered ordinal logistic regression models revealed that patients' WTP decreased with higher risk of adverse effects (P<.001), higher risk of being assigned to placebo (P =.02), and lower payment level (P<.001). There were no significant interactions between payment level and either risk variable, suggesting that increasing payments do not alter peoples' perceptions of risk. There was a trend toward a positive interaction between income and the influence of payment on WTP (P =.09), suggesting that payment more strongly influences WTP among wealthier people. Wealthier patients were more likely to state that payment was important in their participation decision (37% vs 20%, P =.05). CONCLUSION: Although higher payment motivates research participation, we found no evidence that commonly used payment levels represent undue or unjust inducements.

Cognitive function assessment in individuals at risk for Alzheimer's disease.

PURPOSE: To describe brief assessments of functional performance and cognition to detect Alzheimer's disease (AD) and depression in older adults for the primary care provider. DATA SOURCES: Review of the literature. CONCLUSIONS: It is important for the clinician to interview both the patient and a knowledgeable informant to assess changes in the patients' functioning in daily life tasks and to administer brief screening tests to detect cognitive impairment and depression in older adults. Several suggested instruments for use in the primary care setting are included. IMPLICATIONS FOR PRACTICE: Standardized assessments of functional performance and brief cognitive tests identify individuals with clinically meaningful cognitive impairment and provide baseline measurement against which to compare future assessments.

How changes in health care practices, systems, and research challenge the practice of informed consent.

Informed consent has been the central model for ethical decision making in clinical care and research. The goal of informed consent is to protect the right of a competent person to make his or her own health care decisions based on personal values and goals. But changes in health care practices, systems, and research have challenged this well-established goal. This paper examines these changes to show that decisions about care and research directed to individual patients rely more and more upon a population perspective. As a result, efforts to promote patient choice should attend to the ethical decision-making processes of institutions that create and sustain this perspective.

Living with dementia: caregiver perspectives.

About four million Americans currently live with Alzheimer's disease (AD) or related forms of dementia. Because the disease process impairs language, insight, and judgment, family members become "caregivers." These caregivers, either in part or in full, often make decisions on patients' behalf. This Issue Brief summarizes a series of studies that describe how caregivers make decisions for AD patients, and caregiver perspectives on the quality of life for relatives with AD.