Showing papers in "Alzheimer Disease & Associated Disorders in 1997"

Length of clinical trials of dementia drugs : Position paper from the international working group on harmonization of dementia drug guidelines

Abstract: SummaryWe developed a set of informant-based items describing performance of activities of daily living (ADL) by patients with Alzheimer's disease (AD) to identify which ADL are useful for assessment of patients in clinical trials. Evaluation of ADL is an important outcome measure in AD clinical tri

An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study.

Abstract: We developed a set of informant-based items describing performance of activities of daily living (ADL) by patients with Alzheimer's disease (AD) to identify which ADL are useful for assessment of patients in clinical trials. Evaluation of ADL is an important outcome measure in AD clinical trials. For clinical trial measurement, ADL should have broad applicability, good test-retest reliability, scaling to cover a range of performance, and sensitivity to detect change in disease progression. A total of 45 ADL items developed from literature review and clinical experience were administered to informants of 242 AD patients and 64 elderly controls as part of the multicenter Alzheimer's Disease Cooperative Study Instrument protocol. Half of the subjects were re-evaluated at 1 and 2 months and all at 6 and 12 months. Controls performed virtually all ADL items optimally at baseline and at 12 months. Among subjects with AD, 27 of the 45 ADL were widely applicable, i.e., performed at baseline or premorbidly by > 90% of subjects; showed good test-retest reliability between baseline and 1 and 2 months; correlated with MMSE scores of AD patients cross-sectionally; and showed a decline in performance from baseline to 12 months in at least 20% of AD patients. ADL could be identified that capture change in functional ability in patients across the entire range of the MMSE. The remaining 18 ADL included several that may be useful for trials that target specific populations, e.g., women with AD. Because change on specific items depends on baseline MMSE, ADL evaluation should include items relevant to the severity of dementia of patients enrolled in a clinical trial.

Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimer's Disease Cooperative Study.

Abstract: This article reports the development and psychometric properties of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC). At present, a number of unvalidated CGIC scales are used in clinical trials, with various methods for making ratings. The ADCS-CGIC was designed on the basis of a survey of ADCS clinicians and by adapting existing instruments. It includes an organized but unstructured format, with which a clinician can address clinically relevant change. The instrument's reliability and validity were assessed in a prospective trial of Alzheimer's disease (AD) and healthy subjects over a 12-month period. It showed good short-term reliability at 1 and 2 months, with 90 and 94% of AD subjects, respectively, rated as having changed not at all or only minimally. The ADCS-CGIC's face validity was demonstrated by untreated. AD subjects rated as having worsened over time at both 6 months (56% rated as having worsened) and 12 months (81% rated as having worsened), whereas only 2% of control subjects showed minimal worsening. As a measure of predictive validity, ADCS-CGIC ratings at 12 months were significantly associated with change on four severity scales. As with other measures, change ratings were sensitive to dementia severity. Moderately impaired subjects showed greater worsening than other subjects. ADCS-CGIC ratings of greater worsening were made after the informant interview, regardless of whether informants or subjects were interviewed first. The ADCS-CGIC is a valid and reliable instrument for use in clinical trials.

Development of cognitive instruments for use in clinical trials of antidementia drugs: Additions to the Alzheimer's Disease Assessment Scale that broaden its scope.

Abstract: SummaryThe cognitive assessment protocol of the Alzheimer's Disease Cooperative Study (ADCS) was designed to evaluate the reliability and validity of cognitive assessment measures that might be valuable additions to the Alzheimer's Disease Assessment Scale (ADAS) or other concise batteries used in a

Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study.

Abstract: The cognitive assessment protocol of the Alzheimer's Disease Cooperative Study (ADCS) was designed to evaluate the reliability and validity of cognitive assessment measures that might be valuable additions to the Alzheimer's Disease Assessment Scale (ADAS) or other concise batteries used in antidementia drug trials. As part of an overall ADCS protocol to develop new instruments to be used in trials of treatments for Alzheimer's disease (AD), patients with mild to moderate AD and cognitively normal elderly were administered a battery of five tests at least three times over 1 year. The tests included word list learning with delayed free recall, a recognition memory test for faces, a series of letter and digit cancellation tests to measure concentration, tests of praxis, and a series of maze completion tasks designed to assess planning and executive function. A version of the digit cancellation task was reliable and sensitive to a broad range of dementia severity so that it could provide a useful addition to the present version of the ADAS. Performance on the word learning task with delayed recall and a subset of the mazes task were impaired even in mild AD, so these tasks may be useful in trials involving mild or at-risk subjects. Performances on the facial recognition task and on the praxis tasks were not related to dementia severity, so these tasks would not be useful to evaluate treatments. Therefore, the major outcome of this investigation was the identification of some potential additions to the present ADAS that extend both the cognitive domains and the range of symptom severity covered.

Validity and reliability of the Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change.

Abstract: Clinical global impressions of change (CGICs) are important measures of efficacy in clinical trials. CGIC scales have been used extensively as primary outcome criteria in psychopharmacological trials and in early clinical trials for antidementia drugs (e.g., Schneider and Olin, 1994). CGICs have been reported to be the most sensitive index of change in 14 of 17 dementia trials, when compared to other measures (Lehmann, 1984).

Behavior and caregiver burden: behavioral problems in patients with Alzheimer disease and its association with caregiver distress.

Abstract: Behavioral dysfunction in Alzheimer disease (AD) is a major influence on the morbidity and disability of patients and is central to decisions on patient institutionalization. Behavioral dysfunction ranges from withdrawal, apathy, and depression to hostility, anger, and aggression, with most patients exhibiting some symptoms during the course of the disease. Symptoms of depression are common in AD patients (17-30%) and are associated with broad behavioral dysfunction and increased functional disability. Furthermore, the occurrence of depression in patients correlates strongly with caregiver burden and depression. This report summarizes the relationship between caregiver distress and patient behavioral problems. Administration of the Revised Memory and Behavior Problem Checklist provided information on the frequency of behavioral problems and their association with caregiver distress. In one study of 201 patient-caregiver dyads, depression-related behaviors were confirmed as the most distressing to caregivers. In another, the rates of caregiver depression were high (75%) among those caring for clinically depressed AD patients. Indeed, in a third study, 100% of patients with depression had depressed caregivers. The vulnerability of caregivers to depression is linked to their own age, gender, physical ability, personality, and available social supports. Alleviation of caregiver distress, burden, and depression will be of great value in the improvement of AD patient care.

The severe impairment battery: concurrent validity and the assessment of longitudinal change in Alzheimer's disease. The Alzheimer's Disease Cooperative Study.

Abstract: Measurement of cognitive dysfunction in the early stages of Alzheimer's disease (AD) has been well studied and there are many objective tests in use for this purpose. However, with the exception of clinical rating scales, such as the Clinical Dementia Rating Scale, Global Deterioration Scale, and Functional Assessment Staging, there are few objective measures of cognition in the more advanced stages of AD. Given a renewed interest in potential AD therapies, objective measures of mental functioning are needed to adequately assess change in more advanced AD patients. As part of an effort by the NIA-Alzheimer's Disease Cooperative Study to evaluate new measures of efficacy for their utility in treatment studies, the Severe Impairment Battery (SIB) was examined in a 1-year evaluation of change across a wide range of AD severity. The data suggest that the SIB is a reliable and valid measure of progression, particularly in persons with moderate to severe AD. The SIB may therefore be a useful outcome measure in clinical trials that include patients with more advanced stages of AD.

Evaluating the Driving Competence of Dementia Patients

Abstract: The driving behaviors of dementia patients have received little in the way of empirical scrutiny except through retrospective reports of crash rates. Understanding the driving errors of dementia patients and how they differ from those of normal older and younger drivers is important. This knowledge is basic to the development of road tests and scoring procedures to evaluate the driving competence of older, experienced drivers, especially those whose fitness to drive may have been compromised by a medical illness that alters their mental abilities. We have drive tested over 100 currently driving elderly patients with clinically significant cognitive decline (mostly diagnosed as the early stages of Alzheimer disease) and compared their performance with that of normal drivers. The study identified the types of driving errors that distinguish and differentiate the cognitively impaired group as well as a set of driving errors typical of both cognitively impaired and normal experienced drivers but differing in the number and severity of errors. A set of errors was also identified that did not differentiate the groups and should not be used in evaluating a person's competence to drive.

Assessing quality of life in Alzheimer disease research

Abstract: Quality of life (QOL) is defined both conceptually and operationally in terms of essential characteristics of evaluational stance, multidimensionality, and subjective-versus-objective aspects. Necessary dimensions for QOL assessment include both subjective and objective components, specifically attributes falling into sectors of behavioral competence, self-assessed quality of domains of everyday life, environment, and generalized psychological well-being. None of these QOL facets should be excluded from assessment in people with dementia, but many such people require the use of indicators that do not depend on self-report. Existing measures and assessment techniques are discussed as grouped into attribute ratings (single ratings provided by someone who observes the person over some extended period of time) and direct observational methods (only behavior as it is observed in ongoing fashion). Attribute ratings are the domains of time use quality, social interaction, and affect states, and direct observation in domains of behavior, affect display, and environmental quality are discussed.

Assessing patterns of agitation in Alzheimer's disease patients with the cohen-mansfield agitation inventory

Abstract: As part of the effort of the NIA Alzheimer's disease cooperative study to develop improved instruments for quantifying effects in Alzheimer's disease (AD) clinical trials, patterns of agitated behaviors were evaluated with the Cohen-Mansfield Agitation Inventory (CMAI) in 241 AD patients and 64 healthy elderly controls with valid baseline assessment on the CMAI. The test-retest reliability of the CMAI over 1 month was good (r = 0.74 to 0.92). Physically and verbally nonaggressive behaviors were most often reported, whereas physically aggressive behaviors were rare. Frequency of agitated behaviors increased with dementia severity, especially for patients with a Mini-Mental Status Exam score of 0-4. Agitation tended to increase in the evening with dementia severity for the more impaired patients. Amount of agitation did increase after 12 months in all but controls and mildly demented patients. The CMAI shows promise for evaluating a unique aspect of behavior and may be useful in assessing the effects of cognitive enhancers and other types of psychotropic drugs on behavior in dementia patients.

The Severe Impairment Battery : Concurrent validity and the assessment of longitudinal change in Alzheimer's disease

Abstract: SummaryMeasurement of cognitive dysfunction in the early stages of Alzheimer's disease (AD) has been well studied and there are many objective tests in use for this purpose. However, with the exception of clinical rating scales, such as the Clinical Dementia Rating Scale, Global Deterioration Scale,

Slowing the progression of alzheimer disease : Methodologic issues. Discussion

Abstract: The evidence to support a claim that a new drug will slow the progression of Alzheimer disease (AD) must derive from epistemologically valid research methods. Although agency regulations do not specify the magnitude of an effect that a drug must possess to be granted a claim as a treatment for AD, the evidence to support any claim must be adduced in adequate and well-controlled clinical investigations and must meet the standard of "substantial evidence." Because a claim presented in drug product labeling may not be false or misleading in any particular, a distinction must be made between treatments that provide a "symptomatic" benefit and those that alter the course of dementia. Examples of some of the difficulties likely to be encountered by sponsors seeking to develop evidence to support a claim that a new drug slows the progression of dementia are presented. A suggestion is made for a clinical trial design, designated as the "randomized start design," that may be useful in such a question. Why this design might overcome many of the difficulties, both practical and ethical, present in the "discontinuation" design, the design ordinarily proposed to assess a drug's effect on disease progression, is discussed.

Knowledge about Alzheimer disease among primary care physicians, psychologists, nurses, and social workers.

Abstract: Although much of the care of Alzheimer disease (AD) patients and their families is carried out by health professionals who are not specialists in AD or geriatrics, little is known about how knowledgeable these health professionals are about AD. An AD knowledge test was constructed through careful instrument development procedures and then administered through a mail survey. Subjects were 693 individuals, including experts in AD care, generalist health care professionals (primary care physicians, psychologists, social workers, and nurses), nursing students, hospital staff nurses, and assorted health professionals. A 12-item scale with excellent psychometric properties was developed. Experts in AD care performed significantly better than generalist health care professionals on all items. All four groups of generalist health care professionals showed important deficits in fundamental knowledge about AD; for example, only 40% of generalists (vs. 97% of experts) knew that AD is the most common cause of severe memory loss in people over age 65. Results suggest that, although knowledge about assessment and management of AD has increased and has been widely disseminated, many health care professionals remain uninformed about AD. Suggestions for professional education and for use of the UAB AD Knowledge Test for Health Professionals are discussed.

Economic research on Alzheimer disease: a review of the literature.

Abstract: The present review discusses the economic research to date on Alzheimer disease (AD). It focuses on estimates of the costs of AD and on economic evaluations of interventions in the disease. Empirical and conceptual issues concerning the interpretation of costs and the uses of evaluative methodologies also are discussed. We conclude that estimates of the national costs of AD are open to a large margin of uncertainty. We conclude further that significant opportunities exist for new cost-effectiveness or cost-benefit analyses of AD treatments, patient care options, and counselling, respite, or similar programs for AD caregivers.

The selective muscarinic agonist xanomeline improves both the cognitive deficits and behavioral symptoms of Alzheimer disease.

Abstract: The therapeutic effects of selective cholinergic replacement using oral xanomeline, an m1/m4 receptor agonist, were assessed in a multicenter study of 343 patients with Alzheimer disease (AD). Patients were randomized to parallel treatment arms (placebo, 25, 50, and 75 mg t.i.d. xanomeline) and followed through 6 months of double-blind therapy and 1 month of single-blind placebo washout. Completer analysis, using the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), revealed a significant treatment effect (75 mg t.i.d. vs. placebo; p = 0.045). Similar assessment of global status, using the Clinician's Interview-Based Impression of Change, was also significant (75 mg t.i.d. vs. placebo; p = 0.022). Treatment Emergent Signs and Symptoms analysis of the Alzheimer's Disease Symptomatology Scale, revealed highly significant (p < or = 0.002) dose-dependent reductions in vocal outbursts, suspiciousness, delusions, agitation, and hallucinations. On end-point analysis, the Nurses' Observational Scale for Geriatric Patients also showed a significant dose-response relationship (p = 0.018). The improvement in ADAS-Cog provides the first clinical evidence of involvement of the m1 muscarinic receptor in cognition. Furthermore, the favorable effects of xanomeline on disturbing behaviors suggest a novel approach for treatment of the noncognitive symptoms of AD. Although adverse effects (mainly gastrointestinal) associated with the oral formulation appear to limit its use, a large-scale study investigating the safety and efficacy of transdermal xanomeline is under way.

Postural and gait disturbance correlated with decreased frontal cerebral blood flow in Alzheimer disease.

Abstract: In a group of 45 patients with Alzheimer disease (AD) and 15 control subjects, we studied the relationship between parameters showing postural and gait disturbance and regional cerebral blood flow (rCBF) measured with N-isopropyl-p-[123I]iodoam-phetamine single photon emission computed tomography at different clinical stages. Patients with AD with mild dementia exhibited only increased postural sway associated with a reduced mean value of rCBF in the cortex. At a moderate stage, the reduced mean values of rCBF in the cortex and in the frontal lobe were associated with increased postural sway and stride length variability and with decreased stride length. At a severe stage, reduced rCBF in the basal ganglia and in the frontal lobe additionally were associated with increased postural sway, double support time, and stride length variability, and with decreased walking speed and stride length. In multiple regression analysis, there was a high contribution by rCBF in the frontal lobe to account for postural and gait disturbance in AD. We propose that impaired frontal lobe circulation is an important factor causing postural and gait disturbance as AD progresses.

Methods of screening for dementia: a meta-analysis of studies comparing an informant questionnaire with a brief cognitive test.

Abstract: A meta-analysis was performed on 10 studies that directly compared an informant questionnaire with a brief cognitive test at screening for dementia. The effectiveness (effect size) of the screening tests used in each study was measured using the standardized difference between the means of the demented and control samples. The informant questionnaires were found to have a weighted mean effectiveness of 1.74 [95% confidence interval (CI): 1.39-2.09], whereas for the cognitive tests, the mean was 1.48 (95% CI: 1.23-1.73). These means translate into sensitivities and specificites of 0.86 and 0.80 for informant questionnaires, compared with 0.79 and 0.80 for brief cognitive tests. The effectiveness of the informant questionnaires was found to differ significantly from study to study, but the reason for this variation is not clear. It was concluded that informant questionnaires are as effective as brief cognitive tests at screening for dementia and deserve to be used more extensively.

Delirium in Alzheimer disease.

Abstract: Summary:Advanced age and dementia are well-known risk factors for delirium, and most studies of delirium have concentrated on hospitalized populations. We reviewed the records of 199 community-dwelling Alzheimer disease (AD) patients and identified 43 (22%) who had had episodes of delirium during th

Dementia and Driving: An Attempt at Consensus

Abstract: The number of older drivers in Sweden will be rapidly increasing during the next decades. A possible relationship exists between the increased relative crash risk of older drivers and the prevalence of age-related diseases such as dementia. However, a clear-cut policy for evaluating driving competence in demented persons is still lacking. In recognition of this fact, the Swedish National Road Administration invited a group of researchers to formulate a consensus on the issue of driving and dementia. This consensus document is aimed at providing primary care physicians with practical advice concerning the assessment of cognitive status in relation to driving. Suggestions are based on a review of existing research and discuss the use of general and driving-specific sources of information available to the physician. Consensus was reached on the statement that a diagnosis of moderate to severe dementia precludes driving and that certain individuals with mild dementia should be considered for a specialized assessment of their driving competence.

Is decreased use of analgesics in Alzheimer disease due to a change in the affective component of pain

Abstract: Relatively low use of nonsteroidal anti-inflammatory drugs (NSAIDs) and other analgesics has been noted in patients with probable Alzheimer disease (AD). Although this finding has been explained by a decline in patients' capacities to communicate about pain, self-report on pain of cognitively impaired elderly have been shown to be just as reliable as those of cognitively unimpaired elderly. However, previously published studies were aimed primarily at quantifying pain. Considering the various limbic areas affected in AD, a change also in the more qualitative, affective component of pain might be the cause of the low use of analgesics. Because affective disorders are highest in the early and middle stages of AD and decrease in the final stage, it was hypothesized in the present study that not only would the number of AD patients using analgesics would be lower than among a control group but, moreover, analgesic use would be lower in the early and middle stages of AD than in the final stage. The hypothesis was tested by comparing drug use (NSAIDs and analgesic non-NSAIDs) among 66 AD patients with that among 70 elderly people without dementia. The percentage of AD patients using analgesics was indeed significantly lower than among controls, but drug use was not dependent on the stage of AD. Consequently, our findings only partly support the hypothesis.

Principles underlying selection of outcomes in Alzheimer disease research.

Abstract: The purpose of this study was to measure resource consumption associated with the provision of nonmedical care to noninstitutionalized patients with Alzheimer disease (AD) residing in the Lombardy Region of Italy. A questionnaire was mailed to 1,501 caregivers who sought advice from the "Federation Alzheimer Italia" in 1995. On the basis of 616 returned questionnaires, the authors estimated that a patient with AD requires 18 hours per week of paid nonmedical services and 45 hours per week of personal care provided by a primary caregiver. Primary caregivers are more likely to be women, spouses, and retired. Almost 7 of 10 patients are supported by at least a second caregiver. Annual expenditure for nonmedical cost per patient with AD is estimated to be L 13,388,000 (U.S. $8,218). Using the replacement cost approach, the authors estimated the economic cost of informal (unpaid) care to be L 72,877,000 (U.S. $44,736). Despite some limitations in the design of the survey, this first Italian study on primary data highlights the impressive economic burden of AD on families. It also shows that AD puts many Italian families at great financial risk. Adequate and timely funding arrangements should be urgently found to make resources available to future generations of patients.

The potential for using administrative and clinical data to analyze outcomes for the cognitively impaired: an assessment of the minimum data set for nursing homes.

Abstract: Quite frequently, data from administrative or clinical data sets are not considered suitable for research because of concerns about their validity and reliability. The authors discuss the important role that such data sets may play in the future of health care. To provide an indication that all administrative and clinical data bases do not provide inferior data, the authors compare the internal consistency and predictive validity of information from three statewide administrative/clinical databases, focusing on nursing home residents with comparable data from a research database. These databases contain information gathered using the Minimum Data Set (MDS) for Nursing Home Resident Assessment and Care Screening. The two dimensions of status considered in this illustration are cognition and physical function. The results of this comparison indicate that the assessment data in three statewide clinical/administrative databases are as reliable and valid as the data found in the research database. Finally, the authors discuss the precepts one might follow in developing clinical/administrative databases that provide good data. These precepts also can be used as guidelines in the evaluation of the probable usefulness of such databases for assessing outcomes among cognitively impaired nursing home residents.

Measuring quality of life in dementia: Conceptual and practical issues

Abstract: The authors discuss some of the challenges that exist in measuring quality of life in persons with dementia. The issues that arise in measuring QOL in persons with dementia are identified, and the status of instruments that exist or are being developed is reviewed briefly.

How should a group living unit for demented elderly be designed to decrease psychiatric symptoms

Abstract: The main objectives were to study relationships between the design of group living (GL) units and psychiatric symptoms in demented patients before, 6 months after, and 1 year after admission to GL units. The study population comprised 105 demented elderly (83 +/- 6 years), 37% with dementia of Alzheimer's type and 58% with vascular dementia. The patients were relocated by the municipal care planning team after clinical examination. An observational scale (the Organic Brain Syndrome scale) was used to assess confusional symptoms and disorientation. The physical environment was assessed by an architect using the Therapeutic Environment Screening Scale, which evaluates general design, space, lighting, noise, communication area, floor plan, and related factors. Less than 15% of the patients had no signs of dyspraxia, hallucinosis, dysphasia, or depression at admission, whereas 66% or more reported lack of vitality, aggressiveness, or restlessness. Fourteen out of 18 units had a corridor-like design (group A), one unit an L-shaped design (group B), and the others a square or H-shaped design (group C). Patients living in the B unit had less disorientation than the others at the 6-month follow-up. After 1 year, the patients in the A units had more dyspraxia, lack of vitality, and disorientation of identity. The communication areas in the units were negatively associated with "disorientation for recent memory" and "lack of vitality," adjusted for type of dementia (r = -0.13 to -0.16). The size of the activity area, indoor public rooms in square meters, was not correlated to confusional reactions and disorientation. In conclusion, a GL unit design that facilitates perception without reducing the communication area is to be preferred.

Slowing the progression of Alzheimer disease: methodologic issues

Abstract: The evidence to support a claim that a new drug will slow the progression of Alzheimer disease (AD) must derive from epistemologically valid research methods. Although agency regulations do not specify the magnitude of an effect that a drug must possess to be granted a claim as a treatment for AD, the evidence to support any claim must be adduced in adequate and well-controlled clinical investigations and must meet the standard of "substantial evidence." Because a claim presented in drug product labeling may not be false or misleading in any particular, a distinction must be made between treatments that provide a "symptomatic" benefit and those that alter the course of dementia. Examples of some of the difficulties likely to be encountered by sponsors seeking to develop evidence to support a claim that a new drug slows the progression of dementia are presented. A suggestion is made for a clinical trial design, designated as the "randomized start design," that may be useful in such a question. Why this design might overcome many of the difficulties, both practical and ethical, present in the "discontinuation" design, the design ordinarily proposed to assess a drug's effect on disease progression, is discussed.

The 1994 International Consensus Conference on Dementia and Driving: a brief report. Swedish National Road Administration.

Abstract: A possible relationship exists between the increased relative crash risk of older drivers and the prevalence of age-related diseases such as dementia. However, although dementia effects cognitive functions essential for safe driving, the evaluation of driving competence in demented persons is problematic. A clear-cut policy, intended chiefly for primary care physicians, is still lacking. In recognition of this fact, the Swedish National Road Administration invited a group of researchers to review existing research and to formulate a consensus on the issue of driving and dementia. The consensus group suggested that physicians should routinely make a cursory evaluation of the mental condition of their older driving patients. When signs of cognitive impairment are detected, possible influence on visuospatial skills, attention, judgment, and memory functions should be carefully considered. Information from caregivers on past and current driving performance as well as functions relating to activities of daily living (ADL) should be taken into account. Consensus was reached that a diagnosis of moderate to severe dementia indicates sufficient cognitive impairment to preclude driving. In addition, diagnosed mildly demented individuals or nondiagnosed cognitively impaired individuals with functional deterioration should be considered for specialized assessment of driving competence.

Use of proxies to measure health and functional outcomes in effectiveness research in persons with Alzheimer disease and related disorders.

Abstract: As the focus in the study of Alzheimer disease moves from the laboratory and research-oriented care setting to the broader array of community settings where effectiveness research takes place, it becomes necessary to rely less on medical records and reports of health care professionals experienced in following research protocols and more on observers who are not trained to interpret and report their observations in a standardized way. The present paper targets the use of proxy interviews to obtain information about health and functional outcomes for effectiveness research. Included are indications of the type of information that may be obtained from proxies, a discussion of issues surrounding the use of proxies in research on older persons with cognitive impairment, a summary of the current state of knowledge in this area, identification of practical strategies researchers may employ when using proxies, and recommended directions for further research.

The Bedford Alzheimer Nursing Severity Scale for the Severely Demented: Validation Study

Abstract: We evaluated the floor effect and convergent, discriminant, and known-group validity of the Bedford Alzheimer Nursing Severity scale (BANS-s), a rating scale comprising cognitive and functional items recently developed for grading severe dementia. Ninety-nine demented patients (81 females and 18 males aged 55-100 years) in two nursing homes were assessed with the BANS-s, established cognitive and functional scales [Mini Mental State Examination, the extended version of the Clinical Dementia Rating (CDR), Katz's basic activities of daily living, Tinetti balance and gait, and Crichton scales], a behavioral scale (UCLA Neuropsychiatric Inventory), and indicators of malnutrition (Prognostic Nutritional Index). A relevant proportion (40%) of patients scored close to the floor of all scales except BANS-s and CDR, which showed a more uniform distribution of scores throughout the possible range. Convergent validity of BANS-s with the other cognitive and functional scales was good, with Pearson's r ranging from 0.62 to 0.79. Discriminant validity analysis of BANS-s versus the UCLA Neuropsychiatric Inventory showed that the two scales measure different domains (Pearson's r = 0.36). To test known-group validity, all patients were divided into two groups of different severity as defined by the Prognostic Nutritional Index. BANS-s and CDR were the scales with the best ability to discriminate malnourished from nonmalnourished patients. As a further validity test, the 37 patients reaching the floor on other cognitive and functional scales were divided into two subgroups of different dementia severity as defined by the Tinetti scale. BANS-s but not CDR was able to differentiate the two groups.