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.

Capacity to make decisions on medication management in Chinese older persons with mild cognitive impairment and mild Alzheimer's disease.

BACKGROUND: This study aimed to assess if decisional capacity and the four decision-making abilities related to decisions concerning medication management were impaired among community-dwelling Chinese older persons in Hong Kong with amnestic mild cognitive impairment (MCI) and mild Alzheimer's disease (AD), as compared with cognitively normal older adults. METHODS: Two hundred and ninety-one Chinese community-dwelling older adults were recruited. The four decision-making abilities and decisional capacity were assessed by using the Chinese version of the Assessment of Capacity for Everyday Decision-Making (ACED) and independent clinician ratings based on the definition in the UK Mental Capacity Act 2005, respectively. RESULTS: Ninety-nine participants (34%) were diagnosed with MCI and ninety-five (33%) with mild AD. Although almost all (96%) of the participants in the MCI group were found to be mentally competent to make decisions on medication management in clinician ratings, their decision-making abilities as measured by the ACED were significantly lower than those of the cognitively normal controls. CONCLUSIONS: Results from this study suggest that abilities related to decisions on medication management are impaired before the clinical diagnosis of dementia is made. Use of specific and structured assessment of the relevant decisional abilities may enhance clinical judgment.

Rate of decline in Alzheimer disease measured by a Dementia Severity Rating Scale.

OBJECTIVE: To measure clinically relevant change in Alzheimer disease (AD) using a family member-completed Dementia Severity Rating Scale (DSRS) questionnaire. BACKGROUND: Measuring rate of change provides important clinical information. Most neuropsychologic scores change nonlinearly, complicating their use as a predictor of change throughout the illness. METHODS: DSRS and Mini Mental State scores were prospectively collected on 702 patients with AD from first evaluation until they became too impaired to return to clinic. RESULTS: DSRS score increased an average of 4.48 points/y [95% confidence interval (CI): 4.14-4.82] throughout the entire range of severity. In contrast, the Mini Mental State declined an average of 2.15 points/y (95% CI: 1.85-2.46) during the first 2 years, accelerated to 3.83 points/y (95% CI: 3.28-4.38) during the subsequent 3 years, and then slowed to an annual decline of 1.63 points during the last 2 years (95% CI: 0.21-3.05). A younger age of symptom onset was associated with an increased rate of DSRS change (P=0.03). CONCLUSIONS: The DSRS provides a clinical measure of functional impairment in AD that increases about 4.48 points/y from the earliest symptomatic stage until patients become too severely impaired to return to clinic.

Identifying the factors that facilitate or hinder advance planning by persons with dementia.

We performed semistructured interviews with 30 family members of patients with advanced dementia to identify the factors that facilitate or hinder advance planning by persons with dementia. All interviews were analyzed using qualitative data analysis techniques. The majority (77%) of family members reported that their relative had some form of written advance directive, and at least half reported previous discussions about health care preferences (57%), living situation or placement issues (50%), and finances or estate planning (60%) with the patient. Family members reported some themes that prompted planning and others that were barriers to planning. Events that most often triggered planning were medical, living situation, or financial issues associated with a friend or family member of the patient (57%). Barriers to planning included both passive and active avoidance. The most common form of passive avoidance was not realizing the importance of planning until it was too late to have the discussion (63%). The most common form of active avoidance was avoiding the discussion (53%). These data suggest potentially remediable strategies to address barriers to advance planning discussions.

Do Alzheimer's disease patients want to participate in a treatment decision, and would their caregivers let them?

PURPOSE: This study was designed to examine the factors associated with the preferences of Alzheimer's disease patients to participate in a decision to use an Alzheimer's disease-slowing medication and how involved their caregivers would let them be in this decision. DESIGN AND METHODS: Interviews were conducted with 48 patients in the mild-to-moderate stage of Alzheimer's disease and their caregivers. RESULTS: Ninety-two percent of patients indicated they would participate in an Alzheimer's disease treatment decision, whereas 71% of caregivers thought the patient would participate. Half of the caregivers who indicated that their relatives would participate had relatives who did not have the capacity to make the decision based on a consensus of three expert psychiatrists. Patients' insight into their diagnosis and prognosis, and having less cognitive impairment, being a female caregiver, and being a spousal caregiver were all associated with the likelihood that the patient would participate in the treatment decision. Patients talked about wanting to be involved in the process of making a treatment decision, whereas caregivers talked about assessing whether their relative could participate in the process of decision making. IMPLICATIONS: Mild-to-moderate stage Alzheimer's disease patients want to be involved in making treatment decisions, and caregivers are generally willing to involve them. Caregivers of Alzheimer's disease patients talk about patient participation in relation to elements of the capacity to make a treatment decision. Clinicians can provide guidance and education to assist caregivers in understanding how to assess their relatives' abilities to make decisions and navigate the decision-making process.

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.

Alzheimer disease: current concepts and emerging diagnostic and therapeutic strategies.

Alzheimer disease is a complex neurodegenerative dementing illness. It has become a major public health problem because of its increasing prevalence, long duration, high cost of care, and lack of disease-modifying therapy. Over the past few years, however, remarkable advances have taken place in understanding both the genetic and molecular biology associated with the intracellular processing of amyloid and tau and the changes leading to the pathologic formation of extracellular amyloid plaques and the intraneuronal aggregation of hyperphosphorylated tau into neurofibrillary tangles. The identification of disease-causing autosomal dominant mutations as well as gene polymorphisms that alter the risk for pathology indicate that Alzheimer disease is a genetically complex disorder. This progress in our understanding of the molecular pathology has set the stage for clinically meaningful advances in diagnosis and treatment. Emerging diagnostic methods that are based on biochemical and imaging biomarkers of disease-specific pathology hold the potential for accurately diagnosing Alzheimer disease at the earliest stage of the illness--the time when disease-modifying treatment will be most effective. Currently available cholinesterase inhibition therapy targets the cognitive symptoms. However, the goal of new therapies under development is halting the pathologic cascade and potentially reversing the course of the disease. If these new therapies are successful, they will represent a remarkable medical advance for patients and the families who care for them.

Diagnostic evaluation of elderly patients with mild memory problems.

This case-based discussion focuses on the clinical presentation and diagnostic assessment of a uniquely challenging group of elderly patients: those with symptoms of mild memory problems. Such patients present a challenge to clinicians because of flux in our understandings of normal, age-related cognitive changes; of cognitive changes due to neurodegenerative illnesses; and of the relationships between depression and cognitive impairment. In addition, symptoms of memory problems may be reported by an observer rather than by the patient. These challenges warrant stepwise evaluation of elderly patients who present with symptoms of memory loss.

Addressing the challenges of transforming laboratory advances into Alzheimer's Disease treatments.

This essay addresses the challenges of clinical trials to develop treatments for Alzheimer's Disease (AD). The issues covered are enrolling subjects, defining clinically meaningful endpoints, and making the claim that a drug slows the progression of the disease. The perspective to address these challenges is that dementia research should embrace a biopsychosocial model for drug development. In this model, the patient and caregiver are seen as interrelated subjects of both treatment and research and outcome measures reflect biomarkers of the disease, the functional morbidity of AD and the distress of caregiving.

Hypertensive patients' willingness to participate in placebo-controlled trials: implications for recruitment efficiency.

BACKGROUND: Underenrollment and selective enrollment plague many clinical trials. Little is known about why hypertensive patients agree or refuse to participate in placebo-controlled trials (PCT) of antihypertensive drugs, whether the prospect of receiving placebo influences willingness to participate (WTP), or whether patients who participate differ from those who do not. METHODS: We described a hypothetical PCT of a new antihypertensive drug to 126 patients who would be eligible for ongoing phase III trials. We solicited patient motivations and concerns regarding trial participation by using open-ended questions, assessed the patients' stated WTP, and used logistic regression to determine patient characteristics associated with WTP. We reassessed WTP in 62 patients after revealing, in random order, that 10%, 30%, and 50% of patients would receive placebo. RESULTS: The most commonly cited motivations for participating included personal health benefits (40%), helping other patients (37%), and contributing to scientific knowledge (15%). The most common concerns were having to stop current medications (56%), inconvenience/annoyance (38%), fear of known side effects (35%), and the possibility of receiving placebo (24%). Overall, 47% of patients (95% confidence interval, 38% to 56%) were willing to participate. Younger patients (57% versus 37%; P =.01), nonsmokers (50% versus 24%; P =.04), and patients who had participated in research previously (77% versus 20%; P =.009) were all significantly more willing to participate. Fewer patients were willing to participate as the percentage who would receive placebo increased (P =.02), but randomly assigning fully half of patients to placebo still yielded maximal recruitment efficiency. CONCLUSIONS: Hypertensive patients participate in trials for altruistic and personal health reasons. Differences between patients who do or do not participate may influence trial outcomes. The proportion of patients receiving placebo influences some patients' enrollment decisions but is not a key determinant of recruitment efficiency.

Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial.

OBJECTIVES: To examine the capacity, competency, and reasons for enrolling of patients with Alzheimer's disease (AD) and of their caregivers in an early phase AD clinical trial. DESIGN: Interviews were conducted with patients with AD, nondemented older persons, and caregivers. SETTING: Participants' homes. PARTICIPANTS: Fifteen patients with mild to moderate AD, 15 age- and education-matched nondemented older persons, and 15 patient caregivers. MEASUREMENTS: Capacity was measured using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR); a study coordinator who reviewed audiotapes of the capacity interviews judged competency, and the reasons for a decision were determined by coding the capacity interviews. RESULTS: On all measures except the ability to make a choice, patients performed worse than controls (understanding: z = 3.2, P =.001; appreciation: z = 2.8, P =.005; reasoning: z = 3.5, P =.0005), and caregivers (understanding: z = 3.8, P =.0002; appreciation: z = 3.0, P =.003; reasoning: z = 3.6, P =.0003). Using the controls' performance to set psychometric criteria to define capacity, the proportions of patients with adequate understanding, appreciation, and reasoning were six of 15 (40%), three of 15 (20%), and five of 15 (33%). All caregivers and nine of the 15 (60%) patients were competent. Reasons for enrolling typically featured the potential benefit to the patients' health or well-being and altruism that was expressed as a desire to help other patients and their families or a desire to contribute to scientific knowledge. CONCLUSIONS: The MacCAT-CR, in particular its understanding scale, is a reliable and valid way to assess patient capacity and competency to enroll in an early-phase clinical trial. Although many patients have significant impairments in their capacity, some mild-stage patients are competent. Reasons for enrolling in an early-phase trial blend an expectation of therapeutic benefit and a desire to help others.

The development of a rapid screen for caregiver burden.

OBJECTIVES: To develop a shortened screen for burden associated with caring for a patient with Alzheimer's disease (AD). DESIGN: Cross-sectional. SETTING: The Memory Disorders Clinic of an AD center. PARTICIPANTS: Two hundred fifty-one AD patient-caregiver dyads. MEASUREMENTS: Screen for Caregiver Burden (SCB), Center for Epidemiologic Studies Depression scale, Medical Outcomes Short Form, Mini-Mental State Examination, and patient and caregiver characteristics. RESULTS: At least 25% of the sample endorsed eight of the 25 items in the SCB subjective burden (SB) scale. Of these eight items with a prevalence of 25% or greater endorsement, seven items had item-total correlations of 0.55 or greater. The shortened seven-item SCB SB had an alpha of 0.86, indicating that the shortened scale has good internal consistency (Full SCB SB alpha=0.88). The seven-item SCB SB was highly associated with depression and overall mental health measures. CONCLUSION: This shortened version of the SCB allows a clinician to rapidly assess the burden associated with caregiving for a person with AD.

Why would caregivers not want to treat their relative's Alzheimer's disease?

OBJECTIVES: To determine family caregivers' willingness to use Alzheimer's disease (AD)-slowing medicines and to examine the relationships between this willingness, dementia severity, and caregiver characteristics. DESIGN: Cross-sectional survey. SETTING: In-home interviews of patients from the Memory Disorders Clinic of the University of Pennsylvania's Alzheimer's Disease Center. PARTICIPANTS: One hundred two caregivers of patients with mild to severe AD who were registered at an Alzheimer's disease center. MEASUREMENTS: Subjects participated in an in-home interview to assess their willingness to use a risk-free AD-slowing medicine and a medicine with 3% annual risk of gastrointestinal bleeding. RESULTS: Half of the patients had severe dementia (n=52). Seventeen (17%) of the caregivers did not want their relative to take a risk-free medicine that could slow AD. Half (n=52) did not want their relative to take an AD-slowing medicine that had a 3% annual risk of gastrointestinal bleeding. Caregivers who were more likely to forgo risk-free treatment of AD were older (odds ratio (OR)=1.7, P=.04), were depressed (OR=3.66, P=.03), had relatives living in a nursing home (OR=3.6, P=.02), had relatives with more-severe dementia according to the Mini-Mental State Examination (MMSE) (OR=2.29, P=.03) or Dementia Severity Rating Scale (DSRS) (OR=2.55, P=.002), and rated their relatives' quality of life (QOL) poorly on a single-item global rating (OR=0.25, P=.001) and the 13-item quality-of-life (QOL)-AD scale (OR=0.38, P=.002). Caregivers who were more likely to forgo a risky treatment were nonwhite (OR=6.53, P=.005), had financial burden (OR=2.93, P=.02), and rated their relative's QOL poorly on a single-item global rating (OR=0.61, P=.01) and the QOL-AD (OR=0.56, P=.01). CONCLUSION: These results suggest that caregivers are generally willing to slow the progression of their relative's dementia even into the severe stage of the disease, especially if it can be done without risk to the patient. Clinical trials and practice guidelines should recognize that a caregiver's assessment of patient QOL and the factors that influence it affect a caregiver's willingness to use AD-slowing treatments.

Conducting research that involves subjects at the end of life who are unable to give consent.

This paper examines the conditions that describe when it is appropriate to conduct research that enrolls a subject near the end-of-life who cannot provide an informed consent. Specifically, it describes conditions that justify when it is acceptable to expose a person to the risks, burdens or discomforts of an intervention that is not intended to benefit that person but to produce generalizable knowledge that will benefit other people. These conditions are: (1) acceptable research risks, (2) proxy decision making, (3) subject assent and dissent, and (4) subject advance consent.

Identifying ambulatory cancer patients at risk of impaired capacity to consent to research.

Ethicists and others have expressed concerns that some patients with cancer might lack adequate decision-making capacity to give consent for research. Although this concern is plausible, it is not known what patient characteristics might be used to identify those patients who are at risk and who therefore should undergo a formal assessment of decision-making capacity. Forty-five patients with cancer were presented with a description of a randomized controlled trial, accompanied by an Institutional Review Board-approved consent form. Two raters who were blind to all patient characteristics assessed decision-making capacity using the MacArthur Competency Assessment Tool for Clinical Research. These scores were summarized in overall capacity judgments using criteria established by a panel of experts. Subjects also completed a symptom rating scale and a battery of neuropsychiatric tests. No relationship was observed between symptom severity and any domain of decision-making capacity (understanding, appreciation, reasoning, ability to express a choice) or summary judgments. However, several other patient characteristics, including age, education, and selected neuropsychiatric test results, were found to be strongly associated with capacity scores. These data suggest that several patient characteristics, such as age, education, and tests of cognitive functions, may help investigators to identify patients with impaired capacity to give consent for research.

How does an Alzheimer's disease patient's role in medical decision making change over time?

As persons with Alzheimer's disease (AD) lose their ability to make decisions, someone else has to make decisions for them. We performed a prospective cohort study of 77 AD patient-caregiver dyads to examine when this transition occurs. When dementia severity surpassed a threshold marked by a Mini-Mental State Examination (MMSE) score less than 20, the level of caregiver-reported patient involvement in the medical decision-making process declined (Moderate [MMSE = 19-12]: Odds Ratio [OR] = 2.35, 95% confidence interval [95% CI] = 1.01-5.49; P =.048; Severe [MMSE < 12]: OR = 29.38, 95% CI = 5.98-144.25, P <.001). Furthermore, older patients (OR = 1.06, 95% CI = 1.00-1.12, P =.049) and mounting caregiver burden (OR = 1.12, 95% CI = 1.04-1.26, P =.003) were significant independent predictors of transitions to the caregiver-dominated medical decision-making process. These results provide clinicians with prognostic information that can help caregivers understand how their role in decision making will change over the course of a patient's dementing illness.

Relationship between Alzheimer's disease severity and patient participation in decisions about their medical care.

To examine the relationships between Alzheimer's disease (AD) severity and patient participation in decisions about their medical care, we performed a cross-sectional study of 74 caregivers' ratings of the degree to which AD patients participate in making decisions about their medical care. The majority of the caregivers reported that they made the final decisions about medical care (n = 48, 64%), one-quarter (n = 19, 26%) reported an equal role, and a small proportion (n = 7, 9%) reported that the patient made the final decisions. Multivariate models showed that the significant predictors of the patient's participation in decisions about medical care were measures of dementia severity: Mini-Mental State Examination (MMSE) and Clinical Dementia Rating (CDR). Patients with mild-stage disease (CDR = 1 or MMSE > or = 20) are involved in decision making largely in a collaborative role with the caregiver. Beyond mild-stage disease, the clinician can largely expect that the caregiver is making the final decisions. These results illustrate how and when caregivers can expect changes in their decision making role.

Are depressed patients more likely to share health care decisions with others?

OBJECTIVES: To determine whether psychological variables, particularly depression, influence patients' willingness to share medical decisions with family members or friends. DESIGN: Cross-sectional interviews. SETTING: Oncology and general geriatrics outpatient clinics of an urban VA medical center. PARTICIPANTS: Ninety-five patients with a Charlson comorbidity index score greater than 5. MEASUREMENTS: Subjects described the way that they make health care decisions with friends or family as a dichotomous variable ("shared" versus "not shared") and as a 5-point ordinal variable (the degree to which they share decisions). Patients also completed the 15-item version of the Geriatric Depression Scale (GDS), the Global Distress Index of the Memorial Symptom Assessment Scale, and selected tests of cognitive function and health literacy. RESULTS: Patients with a GDS score higher than 5 were more likely to share decision-making (16/26 versus 26/69; odds ratio 2.58; p = 0.040), as were patients who were married (23/35 versus 19/60; odds ratio 3.63; p = 0.001). In multivariable regression models, a short form GDS score higher than 5 was independently associated with a willingness to share decision with others. CONCLUSION: These results suggest that depression may have a clinically significant influence on patients' willingness to share health care decisions with others. Health care providers should be alert to this possibility, particularly when the decision at hand is significant.

Advocacy and activism: missing pieces in the quest to improve end-of-life care.

Increasing attention has focused on end-of-life care and has identified significant deficiencies in access and quality of care. When problems with quality or access to care have been identified for other diseases or conditions, the public has often responded vigorously. This paper describes two kinds of public action that have been effective in improving health care in other areas: advocacy and activism. However, a public response to improve end-of-life care has been muted. We discuss some of the reasons for this lack of response, and propose ways in which providers and funding agencies can work with patients and their families to improve end-of-life care.

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.