Consent and refusal in dementia research: conceptual and practical considerations.

This article discusses types of consent refusals, rates of refusal, factors that affect consent, and methods to increase rates of consent in elderly research participants and in those with dementia in particular. Refusals can be categorized according to several types: complete refusal, refusal that is time-contingent, partial refusal, and contingent agreement. Rates of consent vary greatly across studies of persons with dementia. This variation can also be affected by different methodologies of calculating rates, in addition to differences in content of studies, populations, and procedures. To warrant consent, a study must first be scientifically sound, with a high likelihood of advancing knowledge, and must provide maximal protection to participants. Consent rates are affected by the following factors: levels of anticipated risks and benefits of the study, relationships among the different caregivers involved in the care of the potential subject, the ability of the researcher to properly identify and locate the person who needs to provide consent, characteristics and attitudes of the person providing consent, and the method of obtaining consent, including timing, location, method of presentation, and type of consent requested. An understanding of these issues can assist the researcher in tailoring research procedures so as to maximize rates of consent. It also raises ethical issues that warrant further discussion concerning the process of obtaining consent from and for persons with dementia.

Recruitment rates in gerontological research: the situation for drug trials in dementia may be worse than previously reported.

Recruitment issues pose a major problem in dementia research. This paper aims to clarify issues involved in the recruitment of individuals suffering from dementia for research studies. Five studies conducted by the same research team are analyzed in terms of their recruitment procedures and the obstacles encountered with recruitment. Recruitment rates varied from about 80% to 1%. Rates increased according to perceptions of risk, perceptions of benefits, and exclusion criteria. Pharmacologic studies had much lower recruitment rates than nonpharmacologic studies. Investigators need to limit exclusion criteria as much as possible. The extremely low recruitment rates of pharmacologic studies in frail persons with dementia may render the results irrelevant for that population. Similarly, the major differences in procedures between pharmacologic and nonpharmacologic studies may invalidate comparisons of results among such studies. More attention needs to be given to a systematic reporting of recruitment rates.

Nonpharmacologic interventions for inappropriate behaviors in dementia: a review, summary, and critique.

Inappropriate behaviors are very common in dementia and impose an enormous toll both emotionally and financially. Three main psychosocial theoretical models have generally been utilized to explain inappropriate behaviors in dementia: the "unmet needs" model, a behavioral/learning model, and an environmental vulnerability/reduced stress-threshold model. A literature search yielded 83 nonpharmacological intervention studies, which utilized the following categories of interventions: sensory, social contact (real or simulated), behavior therapy, staff training, structured activities, environmental interventions, medical/nursing care interventions, and combination therapies. The majority are reported to have a positive, albeit not always significant, impact. Better matching of the available interventions to patients' needs and capabilities may result in greater benefits to patients and their caregivers.

Health status of participants of adult day care centers.

This study compared the medical conditions found in 183 participants of 5 suburban adult day care programs to the medical and mental health status of community-dwelling elderly persons. Analysis revealed that adult day care center participants are very similar to the community-dwelling elderly population in most health indicators, but suffer from much higher rates of dementia and associated functional disabilities. Moreover, those day care participants who do not suffer from dementia tend to suffer from a psychiatric disorder (e.g., major depression, adjustment disorder). These results show that adult day care has become a facility with a primary mental health function.

The measurement of health: a comparison of indices of disease severity.

This study compared the utility of different health indicators in frail older people, as a component of a larger study of medical evaluations of 183 adult day care participants in five Maryland centers. Indices examined included: number of disease categories, number of active categories, number of severe categories, number of categories with worsening trajectory, and average severity score. In predicting survival, none of the medical indicators without dementia was a strong predictor of survival. When dementia was included, number of categories with worsening trajectory seemed to be the best indicator of survival, with average severity score being a close second. Among the diagnoses, dementia and its severity were the strongest predictors of survival. Prediction of continuous stay in the community (in contrast to death or entry into a nursing home) was significant for most indices and is easier to predict from medical indices than death. Different indicators provided best utility depending on the criterion applied.

Relationships between psychotropic drug dosage, plasma drug concentration, and prolactin levels in nursing home residents.

This study aimed to characterize the relationships between administered dosages of psychotropic drugs, plasma drug concentration, and prolactin levels in a group of elderly nursing home residents. In a randomized, placebo-controlled, double-blind crossover design study, blood samples were drawn from 47 nursing home residents at least 6 hours after taking either haloperidol, thioridazine, or lorazepam. Correlations between drug dosage and plasma drug levels were significant for haloperidol and thioridazine, but not for lorazepam. Plasma drug levels were below the levels of detection for most of those taking haloperidol. Lorazepam was detected in the blood of 4 of the participants even after 3 weeks of downward titration to placebo and 6 weeks of placebo. Prolactin level was related to administered dosage only in those who were taking haloperidol. For those taking haloperidol or thioridazine, prolactin levels decreased when participants were on placebo. When an older person is taken off lorazepam, the possibility of residual drug in their bodies even 6 weeks after termination of drug use should be considered. Haloperidol may be clinically active in the brain despite no currently detectable plasma drug concentration.

Melatonin for treatment of sundowning in elderly persons with dementia - a preliminary study.

This pilot study investigated the impact of melatonin administration as a clinical intervention for improving sleep and alleviating sundowning in 11 elderly nursing home residents who suffer from dementia. Melatonin is a hormone produced and secreted by the pineal gland in response to darkness, which plays a major role in the induction and regulation of sleep. Melatonin production decreases with age. Age-related sleep disorders are frequently associated with disruption of circadian cycle rhythms, and sometimes with 'sundowning'. Sundowning refers to the manifestation of agitation and/or confusion in the evening hours. Agitation has been linked to sleep disorders. Analysis revealed a significant decrease in agitated behaviors in all three shifts, and a significant decrease in daytime sleepiness. There was a nonsignificant decrease in latency (time to fall asleep) during the evening shift and no significant changes were reported in night-time sleep ratings. The results of this study are important, because finding ways of decreasing sundowning in elderly persons may improve their well being, alleviate the burden of the caregivers, and even enable caregiving in a less restrictive environment.

Heterogeneity in dementia: challenges and opportunities.

The major sources of heterogeneity in the manifestation of dementia are analyzed as stemming from three types of sources: initial predisposing factors, lifelong events, and the current condition. Each of these sources is, in turn, comprised of three general domains: genetic/biologic/medical, psychosocial, and environmental. These influences affect the manifestation of dementia in terms of cognitive, behavioral, self-maintenance, and affective functioning. Mapping the sources and manifestations of this heterogeneity can lead to both a more thorough understanding of people with dementia and the development of management settings and interventions that are more responsive to people with dementia.

Self-identity in older persons suffering from dementia: preliminary results.

In this study, we explored the role-identity of nursing home residents suffering from dementia, as well as the potential for utilizing their enduring sense of self-identity for enhancing their quality of life. Four types of role-identity were explored: professional, family-role, leisure activities, and personal attributes. The methodology included structured interviews and a case study. Participants for the interviews were 38 residents of two nursing homes in Israel. Residents, relatives, and staff members were interviewed to provide information about past roles and the degree to which those roles are maintained in the present, and about strategies for bolstering the sense of self-identity. A large range of roles were identified. All role identities deteriorated significantly, with family roles retaining the greatest prominence in the present. However, much heterogeneity was manifested in all roles. Both staff members and relatives felt that a sense of identity in residents could be enhanced in most of the residents, which would exert a beneficial effect on their well-being. Caregiving respondents anticipated that this improvement would be substantial for about half of the residents. The case study illustrates how self-identity can change throughout dementia, and how it can be utilized to improve quality of life.

Mental status change in older surgical patients. Cognition, depression, and other comorbidity.

The authors studied patients age 60 and over to assess the effect of elective surgery as a precipitating factor for cognitive decline over the postoperative year. They found an association between change in test performance and age, physical disability, and number of depressive symptoms. However, persistent decline in Mini-Mental State Exam scores was associated with identifiable factors related to the initial surgery in only 3/ 251 (1 percent of cases). Depression and new onset of acute illness were confounding factors in the assessment of cognitive decline.

Longitudinal predictors of non-aggressive agitated behaviors in the elderly.

Longitudinal predictors of physically and verbally non-aggressive inappropriate behaviors were examined in 200 community-dwelling elderly persons attending senior day care centers. Models based on ratings obtained from staff members and family caregivers were compared. Multiple factors contributed simultaneously to the prediction of non-aggressive behaviors. Similar to previous cross-sectional results, physically non-aggressive behaviors were predicted mainly by good health and cognitive impairment. In addition, depression emerged consistently as a predictor of physically non-aggressive behaviors in all models. Verbally non-aggressive behaviors were predicted by depressed affect and pain, confirming previous suggestions that these behaviors are related to discomfort. The relationship of these behaviors with cognitive functioning was relatively weak. Understanding the etiologies of non-aggressive problem behaviors can aid in developing appropriate care for this population.

Withdrawal of haloperidol, thioridazine, and lorazepam in the nursing home: a controlled, double-blind study.

BACKGROUND: Ongoing regimens of haloperidol, thioridazine, and lorazepam are commonly administered to manage behavior problems in nursing home residents. Nevertheless, there is controversy over whether periodic drug withdrawal should be attempted when those medications are prescribed. This study addressed that issue by examining the effects of discontinuing treatment with haloperidol, thioridazine, and lorazepam among residents of a large suburban nursing home. METHODS: In a double-blind, crossover study, half of 58 nursing home residents (43 women and 15 men with a mean age of 86 years) continued to take the psychotropic medication they had been prescribed, whereas the other half were tapered to placebo. After 6 weeks of taking placebo or original drug, patients were tapered to the reverse schedule and remained on it for 6 weeks. Assessments included informant ratings by the nursing staff who completed the Brief Psychiatric Rating Scale and the Cohen-Mansfield Agitation Inventory. RESULTS: Analyses comparing residents taking placebo to those taking medication after completion of the first phase showed no impact of drug therapy discontinuation on their behavior. Similarly, using the crossover design to compare residents' behaviors while taking placebo vs. taking drugs, withdrawal of medication had no impact on Cohen-Mansfield Agitation Inventory or Brief Psychiatric Rating Scale scores. CONCLUSIONS: Results of this work suggest that longterm use of haloperidol, thioridazine, and lorazepam in nursing homes to manage agitation should be closely monitored for their efficacy. Furthermore, routine attempts at drug withdrawal should be considered for most residents taking psychotropic medication.

Outdoor wandering parks for persons with dementia: a survey of characteristics and use.

This study aimed to characterize the features of outdoor areas for persons with dementia, and to clarify the relationship between design features, use, and satisfaction with these areas. A national survey of long-term care facilities with outdoor areas investigated the characteristics and features of these areas, and how those related to their perceived impact on their users. Most respondents rated outdoor spaces as very useful, and as having a great benefit for users. The perceived benefit was related to the presence of more design features, such as the presence of gazebos and to the number of activities offered in the area. Despite these positive findings, respondents stated the areas were not used as much as possible and indicated several problems, mostly related to the safety of the residents. The results of this survey can assist facilities in better designing or improving their outdoor areas to increase use and satisfaction.

Measurement of inappropriate behavior associated with dementia.

Inappropriate behaviors in dementia affect caregivers, causing depression, burden, stress, and affecting caregivers' social life, morale, and somatic health. These behaviors also may signal that the elderly individuals with dementia are distressed and because of a combination of inappropriate behaviors and loss of communication skills, these individuals may not receive adequate assessment or treatment. This article discusses the assessment of behavior problems in elderly individuals suffering from dementia. The following issues are addressed: the need for assessment; difficulties in assessment of inappropriate behaviors; approaches to the assessment of behavior problems, including caregiver ratings, observational methods, and technological devices; and issues in the clinical use of assessments.

Predictors of mortality in nursing home residents.

A prospective cohort study was conducted to examine predictors of mortality in the nursing home. Participants were 399 long-term nursing home residents, who were followed up for 11 years at the end of which 380 had died, 16 were still alive, 2 were discharged with unknown status, and 1 was alive when discharged. The median duration from baseline to death was 2.75 years. For cognitively intact residents, male gender, larger number of medical diagnoses, and manifestations of physically nonaggressive agitated behaviors (e.g., restlessness, pacing) were significant predictors. For cognitively impaired residents, the significant predictors were older age, impaired activities of daily living, and screaming behavior at a high frequency. Cognitive impairment is important both in predicting death in this population and in understanding the impact of other predictors. The impact of agitated behaviors, quality of social relations, and appetite on mortality highlights issues of quality of life at the end of life.

Estimating the cognitive ability of nursing home residents from the minimum data set.

Two methods have been developed for using the Minimum Data Set (MDS) to estimate cognitive ability, the Cognitive Performance Scale (CPS) and the MDS Cognition Scale (MSD-COGS). The relative utility of the two scales was compared by correlating them with the Mini-Mental State Exam the Global Deterioration Scale in a sample of 290 nursing home residents with a mean age of 87 years. Both the CPS and the MDS-COGS related quite strongly to the Mini-Mental State Exam and to the Global Deterioration Scale, with the MDS-COGS correlating at slightly higher levels than the CPS. The CPS and the MDS-COGS both provide a simple, straightforward method of assessing cognitive function that is easy to understand and clinically meaningful. Because both are derived from the MDS, administration costs, as compared with that of the Mini-Mental State Exam or the Global Deterioration Scale, are also substantially lower. Inasmuch as the data are already available and the procedure is so simple (particularly with the MDS-COGS), it might be of benefit to include a computation of cognitive function as part of the MDS profile.

Predictors of aggressive behaviors: a longitudinal study in senior day care centers.

Aggressive behaviors place elderly persons and their caregivers at risk. This study examines longitudinally the predictors of aggressive behaviors based on staff and family members' ratings of 200 community-dwelling participants from senior day care centers. The main difference between physically and verbally aggressive behaviors was found to be the role of physical and mental health. Cognitive impairment and poor quality of relationship were the main predictors of physically aggressive behaviors. Verbally aggressive behaviors were predicted mainly by depressed affect, low quality of relationships, and poor physical health. These results validate and expand prior cross-sectional research on the correlates of aggression in other populations, and guide in the development of interventions.

Which stress matters? The examination of temporal aspects of stress.

In this study, the impact of past experiences, present stressors, and expectations of future stress on psychological distress were explored. Participants were 38 male and 41 female spouses of patients hospitalized with non-life-threatening diseases. Participants completed questionnaires on which they appraised past, present, and future stressors and described their levels of psychological distress. Five models of the relationships between appraisals of past, present, and future stressors with psychological distress were examined. Only one model was confirmed by the data. It suggests that an appraisal of past stressors affects the appraisal of present stressors only indirectly, through its effect on the appraisal of future stressors. This model also maintains that only the appraisal of present stressors affects psychological distress directly. The implications of these findings for stress research are discussed.