Empowering patients with dementia to make legally effective decisions: a randomized controlled trial on enhancing capacity to consent to treatment.

Objectives: As our society ages, the incidence of age-related diseases increases and with it the number of medical treatments that require informed consent. Capacity to consent is often categorically questioned in persons with dementia (PwD) without appropriate assessment, depriving them of their right to autonomous decision-making. Supportive structures for PwD that comply with legal requirements are lacking. The EmMa project tried to overcome this shortcoming by developing and testing possible supportive measures to enhance the informed consent process for PwD.Method: These enhanced consent procedures (ECPs) were tested in a randomized controlled trial with 40 PwD. It was hypothesized that strengths-based ECPs could improve capacity to consent to a drug treatment in PwD as measured with a semi-structured interview.Results: Against the expectations, no effect of the ECPs on capacity to consent could be found, but the ECPs improved understanding of information in PwD.Conclusion: To empower PwD in clinical settings, however, all aspects of capacity to consent should be targeted with specific aids that are implemented carefully and selectively. More research on possible aids for ECPs is urgently needed in order to enable ethically and legally robust informed consent. In particular, effective ways to improve both reasoning and appreciation are yet to be found.

Observational assessment of communication to empower patients with dementia to make legally effective decisions - revalidation of CODEMamb.

Objectives: Communication enables humans to exercise their rights. Dementia research consistently shows that communication skills decrease as the disease progresses. Nonverbal communication abilities decline more slowly than verbal skills and often become more important as the disease advances. However, resources and deficits in nonverbal and verbal communication behavior differ between persons with dementia and contexts. Knebel et al. proposed the observational assessment tool CODEMamb that we believe to be the first standardized instrument to differentiate between content-related and relationship aspects of nonverbal communication behavior. Until now, evaluations of CODEMamb have been exploratory and used small samples.Method: We therefore retested the psychometric criteria of CODEMamb in persons with a suspected dementia in an ambulatory setting. Data was drawn from 326 older adults (aged 52 - 91) during routine screening in Germany.Results: Our findings support the three-factorial structure of CODEMamb. Internal consistency of the overall scale and the three subscales of CODEMamb was high. Correlations with CERAD-NP subscales revealed similarities to CODEMamb, indicating sufficient convergent validity. Finally, CODEMamb was able to differentiate between persons according to the stage of their disease.Conclusion: CODEMamb is a theoretically based, reliable and valid observational assessment tool and its use in ambulatory settings can help foster individual, person-centered communication by identifying the resources of people with dementia, thereby empowering them in rights-exercising situations.

Assessing capacity to consent to treatment with cholinesterase inhibitors in dementia using a specific and standardized version of the MacArthur Competence Assessment Tool (MacCAT-T).

BACKGROUND: The use of assessment tools has been shown to improve the inter-rater reliability of capacity assessments. However, instrument-based capacity assessments of people with dementia face challenges. In dementia research, measuring capacity with instruments like the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) mostly employ hypothetical treatment vignettes that can overwhelm the abstraction capabilities of people with dementia and are thus not always suitable for this target group. The primary aim of this study was to provide a standardized real informed consent paradigm that enables the dementia-specific properties of capacity to consent to treatment in people with dementia to be identified in a real informed consent process that is both externally valid and ethically justifiable. METHODS: The sample consisted of 53 people with mild to moderate dementia and a group of 133 people without cognitive impairment. Rather than using a hypothetical treatment vignette, we used a standardized version of the MacCAT-T to assess capacity to consent to treatment with cholinesterase inhibitors in people with dementia. Inter-rater reliability, item statistics, and psychometric properties were also investigated. RESULTS: Intraclass correlations (ICCs) (0.951-0.990) indicated high inter-rater reliability of the standardized real informed consent paradigm. In the dementia group, performance on different items of the MacCAT-T varied. Most people with dementia were able to express a treatment choice, and were aware of the need to take a tablet. Further information on the course of the disorder and the benefits and risks of the treatment were less understood, as was comparative reasoning regarding treatment alternatives. CONCLUSION: The standardized real informed consent paradigm enabled us to detect dementia-specific characteristics of patients' capacity to consent to treatment with cholinesterase inhibitors. In order to determine suitable enhanced consent procedures for this treatment, we recommend the consideration of MacCAT-T results on an item level. People with dementia seem to understand only basic information. Our data indicate that one useful strategy to enhance capacity to consent is to reduce attention and memory demands as far as possible.

Neurocognitive Deficits and Effects of Cognitive Reserve in Mild Cognitive Impairment.

BACKGROUND/AIMS: Mild cognitive impairment (MCI) is a frequent syndrome in the older population, which involves an increased risk to develop Alzheimer's disease (AD). The latter can be modified by the cognitive reserve, which can be operationalized by the length of school education. MCI can be differentiated into four subtypes according to the cognitive domains involved: amnestic MCI, multiple-domain amnestic MCI, non-amnestic MCI and multiple-domain non-amnestic MCI. While neurocognitive deficits are a constituent of the diagnosis of these subtypes, the question of how they refer to the cognitive reserve still needs to be clarified. METHODS: We examined neuropsychological deficits in healthy controls, patients with MCI and patients with mild AD (n = 485) derived from a memory clinic. To reduce the number of neuropsychological variables, a factor analysis with varimax rotation was calculated. In a second step, diagnostic groups including MCI subtypes were compared with respect to their clinical and neuropsychological characteristics including cognitive reserve. RESULTS: Most MCI patients showed the amnestic multiple-domain subtype followed by the pure amnestic subtype, while the non-amnestic subtypes were rare. The amnestic subtype displayed a significantly higher level of cognitive reserve and higher MMSE scores than the amnestic multiple-domain subtype, which was in most cases characterized by additional psychomotor and executive deficits. CONCLUSIONS: These findings confirm earlier reports revealing that the amnestic multiple-domain subtype is the most frequent one and indicating that a high cognitive reserve may primarily prevent psychomotor and executive deficits in MCI.

CODEMamb - an observational communication behavior assessment tool for use in ambulatory dementia care.

INTRODUCTION: Communication improves well-being and quality of life for both people with dementia and their professional and family caregivers. Individualized communication, as required in informed consent procedures and psychosocial interventions, can improve quality of life, especially in ambulatory settings. However, few valid and reliable instruments exist that enable communication to be assessed and communication and behavioral resources to be identified. We, therefore, extended and adapted the newly developed observational instrument CODEM for use in ambulatory settings (CODEMamb). METHODS AND RESULTS: Reliability and validity of the new instrument were studied in a total of 171 patients, whereby principal component analysis revealed three important factors: relationship aspects, verbal communication behavior and nonverbal communication behavior. CODEMamb[Formula: see text]s internal consistency, interrater and retest reliability were satisfactory to excellent. Convergent validity indices, as shown by examining correlations with similar but not identical constructs (CERAD-NP verbal subscales), were medium-high, while the divergent validity index (constructional praxis) was relatively low. The relationship to peer-rating remained nonsignificant. Criterion validity was investigated in groups of patients in accordance with their cognitive status. As expected, verbal communication abilities deteriorate faster than the relationship aspects of communication as the disease progresses. CONCLUSIONS: In summary, CODEMamb is a reliable and valid instrument that can be used to collect important information with the ultimate aim of supporting communication with people with dementia.

Need for and challenges facing functional communication as outcome parameter in AD clinical trials.

This paper (1) highlights the relevance of functional communication as an outcome parameter in Alzheimer disease (AD) clinical trials; (2) identifies studies that have reported functional communication outcome measures in AD clinical trials; (3) critically reviews the scales of functional communication used in recent AD clinical trials by summarizing the sources of information, characteristics, and available psychometric data for these scales; and (4) evaluates whether these measures actually or partially assess functional communication. To provide direction for future research and generate suggestions to assist in the development of a valid and reliable functional communication scale for the needs of AD clinical trials, we have included not only functional communication scales, but also related concepts that give thought-provoking impulses for the development of a functional communication scale. As outcome measures for AD clinical trials, the 6 identified papers use 6 different scales, for functional communication and for related concepts. All of the scales appear to have questionable psychometric properties, but still provide a promising basis for the creation of a functional communication scale. We conclude with concrete suggestions on how to combine the advantages of the existing scales for future research aimed at developing a valid and reliable functional communication scale for the needs of AD clinical trials.

Autobiographical Memory in Healthy Aging: a Decade-long Longitudinal Study.

Autobiographic memory (AM) - which is generally considered to be the most advanced human memory system - is subject to a myriad of psychological and neurobiological factors. We, therefore, examined AM longitudinally during the transition from midlife to young-old age and from young-old to old age in two birth cohorts (born 1930-1932 and 1950-1952) hence starting at age 55.14 ± 0.94 vs. 73.85 ± 0.96, respectively. Participants (n = 239) of the Interdisciplinary Longitudinal Study on Adult Development and Aging were recruited of whom 166 could be reexamined after 9 ± 0.9 years. AM was investigated for three periods of life using an established semi-structured interview; potential cognitive decline was assessed on a broad test battery. All subjects stayed cognitively healthy. Analysis of variance with repeated measures revealed age-related semantization effects with a significantly lower number of specific and thereby a higher number of general AMs exclusively from young-old to old age. This effect did not coincide with cognitive decline. In the follow-up period, a significant decrease of event-related details was significantly more pronounced in the young-old than in the old cohort and details were better recalled by the young than the old cohort. At baseline, this difference was significant for the recent past only but involved all periods at follow-up. According to our findings, AM changes in healthy aging accelerate during the transition from young-old to old age and may herald other cognitive deficits. Additionally, these AM changes in cognitively healthy subjects point at an economic process of adaptation.